JP2009530051A - Medical devices and systems - Google Patents

Abstract

Some embodiments of the present invention generally relate to a medical visualization system that includes a combination of disposable and reusable components such as catheters, functional handles, hubs, optical devices, and the like. Another embodiment of the present invention generally relates to features and aspects of an in-vivo visualization system that includes an endoscope having a working channel for delivering a catheter having endoscopic functionality. The catheter can gain endoscopic function by being configured as an endoscopic catheter or by having other viewing devices that are selectively routed through a fiberscope or one of its channels. The catheter is preferably of the steerable type so that the distal end of the catheter can be steered from its proximal end when advanced with the body. Some embodiments of the invention relate to in-vivo visualization devices and systems that include user-actuated control functions and steering devices.

Description

  Embodiments of the present invention generally relate to medical devices. Some embodiments generally relate to medical catheters having steering and / or optical functions. Another embodiment relates generally to medical systems such as in vivo visualization systems suitable for observing and / or executing diagnostic and therapeutic modalities within the human body, such as within the biliary system.

  An accurate visualization of the target area has been a challenge in observing and treating areas within the anatomy of the human body. In a minimally invasive procedure in which an elongated instrument, such as a catheter or endoscope, is moved through a passage in a patient's body into the tube or to a region of interest within the organ reachable from the tube, Visualization can be particularly troublesome.

  Detailed information about the biological tissue can be clearly understood by directly observing the biological tissue provided by one or more elongated instruments used during the procedure. Different types of endoscopes set up for use in various passages of the body such as the esophagus, rectum or bronchus can be used for direct endoscopic functions by the use of optical fibers extending in the length of the endoscope, or A digital sensor such as a CCD or CMOS can be provided. However, because an endoscope or other medical instrument also includes a working channel that needs to pass through, a bundle of optical illumination, and components to provide operational functions at its distal end, the endoscope is Typically, the diameter is relatively large, for example, 5 mm or more. Because of this large diameter, the use of endoscopes for relatively large body lumens is limited and cannot be used in smaller vessels and organs that branch off from large body lumens such as the biliary system.

  Typically, when examining narrow passages such as bile ducts or pancreatic ducts, an endoscope is used to access a smaller passage or region of interest, and other instruments such as catheters are placed on the endoscope. Extends through the working channel into narrower passages. Endoscopes can directly visualize large human passageways and entrances to adjacent tubes and lumens, but smaller catheters have been extended from the endoscope to smaller tubes or lumens Later, direct visualization has traditionally been limited, and surgeons typically rely on radiographic means to visualize the area of interest or explore by hand.

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This summary is set forth to introduce the concept in a simplified form, and the concept is further described below in "Best Mode for Carrying Out the Invention". This summary is not intended to identify key features of the claimed subject matter, but is intended to assist in determining the scope of the claimed subject matter.

  In one embodiment, the present invention controls a control handle, an insertion tube operatively connected to the control handle including a channel extending longitudinally through the tube, and at least one function of the medical device. A medical device including a control function operable by a user of the device. The control function includes a stylet having a proximal end associated with the control handle and a free distal end associated with the insertion tube, the stylet being movably carried by the control handle along at least a portion of the channel. The stylet can redirect the distal end of the insertion tube during user input occurring at the control handle.

  In another embodiment, the present invention is a catheter having a proximal end and a distal end, the catheter including at least one steering wire and a first in communication with the second opening. A mounting structure configured for selectively associating the opening with a port of an associated endoscopic device with a control handle, and a maneuver connected to at least one maneuvering wire to redirect the distal end of the catheter A medical system including an input device is provided. The proximal end of the catheter is operably connected to the control handle, and the distal end of the catheter is associated with the control handle for insertion into a port of the associated endoscopic device when associated therewith. Inserted into the first opening and exits the second opening of the control handle.

  In another embodiment, the present invention provides a catheter having a proximal end and a distal end, and a catheter attached to the distal end of the catheter such that the distal end of the catheter is turned in at least one direction. A steering wire that is axially movable relative to the handle housing and a handle housing that is operatively connected to the proximal end of the catheter at the connection interface, wherein the proximal end of the at least one steering wire enters the handle housing; A handle housing, and a first knob rotatably supported by the handle housing, the rotation axis of the knob being substantially parallel to the central axis of the catheter at the connection interface of the handle housing; A catheter assembly including a transmission wire connected to at least one knob by a steering wire.

  In another embodiment, the present invention is an insertion tube having a control handle and a proximal section and a distal section, wherein the proximal section is functionally attached to the handle and the distal section is a proximal section. Is attached to the distal section of the insertion tube and the distal section of the insertion tube and can be turned to at least one direction A steering wire that is axially movable relative to the insertion tube and is movably carried by the handle and is adapted to control the change in orientation of the distal section relative to the handle during operation of the device An apparatus is provided that includes an input device movable by a user and a transmission connected at a first portion to a steering wire and connected at a second portion to the input device. The transmission is configured to transmit the movement of the input device to the steering wire to change the orientation of the distal end of the insertion tube by axial movement of the steering wire, the transmission further comprising a distal section Is configured to provide a distance amplification effect in the transmission of the movement of the input device to the axial movement of the steering wire.

  The above aspects and many of the attendant advantages of the present invention will be more readily understood by reference to the following detailed description, taken in conjunction with the accompanying drawings, in which:

  Next, embodiments of the present invention will be described with reference to the drawings (similar numerals correspond to similar elements). Embodiments of the present invention are broadly applicable types of medical applications that are desirable for inserting one or more steerable or non-steerable imaging devices, catheters or similar devices into a body lumen or passageway. Related to the system. In particular, some embodiments of the present invention generally relate to medical devices, systems and components, such as catheters, control handles, steering mechanisms, observation devices, and the like.

  Some embodiments of the present invention generally relate to features and aspects of an in-vivo visualization system that includes an endoscope having a working channel through which a catheter having a display function is routed. The catheter is preferably of a steerable type so that the distal end of the catheter can be steered from its proximal end as it is advanced into the body. Suitable uses of in vivo visualization systems include, but are not limited to, diagnosis and / or treatment of the duodenum, particularly the biliary system. Another embodiment of the invention relates generally to the features and aspects of in-vivo visualization system components including a steering mechanism, a control handle, and a catheter assembly.

  Some embodiments of the present invention provide a medical device, such as a catheter, that incorporates endoscopic features such as illumination and visualization functions for endoscopically observing the structure of biological tissue within the body. Including. As such, embodiments of the present invention can be used for a variety of different diagnostic and interventional procedures. Although exemplary embodiments of the present invention are described below with reference to a duodenoscope, aspects of the present invention have a wide range of uses, including other endoscopes (eg, ureteroscopes) or catheters ( It will be appreciated that it may be suitable for use with medical devices such as guide catheters, electrode catheters, angioplasty catheters and the like. Accordingly, the following description and the drawings herein are to be taken as illustrative in nature and are not intended to limit the scope of the invention as recited in the claims. Furthermore, a catheter having a visual function can be used alone or with a conventional endoscope.

  FIG. 1 illustrates an exemplary embodiment of an in-vivo visualization system 120 constructed in accordance with the present invention. The visualization system 120 includes an endoscope 124, such as a duodenoscope, to which a catheter assembly 128 is operatively connected. As described in more detail below, the catheter assembly 128 includes a catheter 130 and a catheter handle 132. The visualization system 120 further includes an observation device 1870, such as a fiberscope (see FIG. 35), or other miniature imaging device that can be sent by the channel of the catheter 130 to observe objects at its distal end. be able to.

  In one suitable application, the endoscope 124 is first introduced into the patient's esophagus and advanced through the stomach to reach the duodenum, near the entrance to the common bile duct (also known as the nipple). After positioning the endoscope 124 adjacent to the bile duct inlet, the catheter 130 of the catheter assembly 128 passes through the distal end of the endoscope 124 and advances to the common bile duct inlet. Alternatively, the catheter 130 can be delivered prior to endoscope insertion. Once in the common bile duct, the fiberscope allows the surgeon to observe tissue, pancreatic duct and / or liver in the bile duct for diagnosis and / or treatment.

  It will be appreciated that selection of the catheter material and the use of an insertable and removable optical device allows the catheter to be configured as a disposable device. Once the procedure is performed, the catheter can be removed from the endoscope and discarded, while the optical device can be removed and sterilized for reuse.

  As best shown in FIG. 1, one suitable embodiment of the endoscope 124 includes an endoscope handle 140 and an insertion tube 142. The insertion tube 142 is an elongated, flexible body that extends from the distal end of the endoscope handle 140. In one embodiment, the insertion tube 142 includes an articulation 144 and a distal tip 146 that are disposed in a distal region thereof. The insertion tube 142 is made of a known material such as polyether block amide (eg, Pebax®), polyurethane, polytetrafluoroethylene (PTFE), and nylon.

  As best shown in the cross-sectional view of FIG. 2, the insertion tube 142 extends throughout its length and includes a variety of guidewires, biopsy forceps, and steerable catheter 130 (FIG. 1). A working channel 150 is defined that allows passage of a therapeutic or diagnostic device. The insertion tube 142 further includes one or more lumens for the purpose of facilitating insertion and extraction of fluids, gases, and / or additional medical devices into and out of the body. For example, the insertion tube 142 can include an irrigation and / or insufflation lumen 152 and an optional inhalation lumen 154. The insertion tube 142 further includes one or more lumens for the purpose of providing an endoscopic observation procedure. For example, the insertion tube 142 includes one or more lumens 156 that extend the entire length of the catheter and can deliver light and fiber optic bundles 158 and 160 to its distal end. Alternatively, the insertion tube 142 can include one or more LEDs and an image sensor such as a CCD or CMOS to capture an image at the distal end and transmit it to the endoscope handle 140. Finally, the insertion tube 142 is connected to at least one set of steering wires 162a and 162b, preferably the distal end of the insertion tube and terminates within the proximal end of the insertion tube 142. 164b including two sets. It will be appreciated that the insertion tube 142 may include other features not shown but known in the art.

  Referring again to FIG. 1, the proximal end of the insertion tube 142 is operatively connected to the distal end of the endoscope handle 140. At the proximal end of the endoscope handle 140, an eyepiece 166 that allows a user to display an image communicated by the fiber optic bundle 160 (see FIG. 2), and an optical cable 168 (connected to an external source of light) (See FIG. 1). Although the endoscope shown in FIG. 1 includes an eyepiece, the endoscope may be of the electrical type, omitting the eyepiece, and the distal end of the endoscope The image obtained from is transmitted to the video processor through an optical cable 168 or other suitable transmission means and displayed by a suitable display device such as an LED monitor. Light from the light source can be transmitted to the distal end of the insertion tube 142 through the optical fiber bundle 158. Endoscope handle 140 further includes steering wires 162a, 162b, and in a conventional manner to redirect the distal end of insertion tube 142 in one or more directions, as illustrated in the form of a control knob. It includes a steering mechanism 170 connected to 164a, 164b (see FIG. 2). The endoscope handle 140 further includes a biopsy port 172 connected in communication with the working channel of the insertion tube 142 that provides access to the working channel of the insertion tube 142 from a location external to the endoscope handle 140.

  The in-vivo visualization system 120 further includes a steerable catheter assembly 128 described in more detail below. As best shown in FIGS. 3 and 4, one suitable embodiment of the catheter assembly 128 includes a catheter handle 132 from which the catheter 130 extends. Catheter 130 includes an elongate, preferably cylindrical, catheter body 176 that extends the entire length of catheter 130 from catheter proximal end 178 to catheter distal end 180. In one embodiment, the catheter body 176 has an outer diameter that is about 5 to 12 French, and preferably about 7 to 10 French. The catheter body 176 is made of Pebax® (polyether block amide), nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane, fluorinated ethylene propylene (FEP), thermoplastic elastomer, etc., or combinations thereof It can be composed of a suitable material. The body 176 is a single material using techniques known in the art, such as extrusion, or multiple materials by thermal bonding, adhesive bonding, lamination, or bonding of multiple extrusions by other known techniques. Can be formed. In a preferred embodiment of the present invention, the distal segment of the catheter (about 1-2 inches where the bend occurs) is more flexible (ie, less rigid) than the rest of the catheter. Made of.

  In the embodiment illustrated in FIG. 3, the catheter body 176 includes a proximal section 182 that extends the majority of the catheter 130, a turning section 184, and a distal tip section 188. In the catheter 130, there is preferably a change in the rigid body between the proximal section and the distal tip section. More preferably, the proximal section 182 is stiffer than the turning section 184. This allows the catheter to reorient to the section 184 that reorients due to a change in the orientation of the distal end 180, while not compressing and can be easily advanced with minimal twisting. . In one embodiment, the proximal section 182 has a durometer value of 35 to 85 Shore D, preferably 60 to 80 Shore D, and the turning section 184 is 5 to 55 Shore D, preferably 25 to 25 Shore D. It has a durometer value of 40 Shore D.

  FIG. 5A is a cross-sectional view of one embodiment of a catheter body 176. The catheter body 176 extends the length of the catheter and defines a working channel 192 that allows passage of various therapeutic or diagnostic devices such as guidewires, stone retrieval baskets, lasers, biopsy forceps and the like. In one embodiment, the working channel 192 preferably has a diameter sufficient to accept up to 4 French actuation devices such as biopsy forceps. The catheter body 176 can further include a fiberscope, fiber optic cable, optical assembly or other small diameter observation device (eg, 0.25 mm to 1.5 mm diameter) that can be fed to the distal end of the catheter 130. A channel 194 may be included that extends throughout the length. The catheter body 176 can further include additional channels 196, 198 for use as a wash channel or additional working channel. Channels 196, 198 each extend the entire length of the catheter and, like working channel 192, allow the passage of devices, liquids and / or gases to or from the treatment area. Each of these channels 196, 198 has a diameter similar to or smaller than the main working channel and can be positioned symmetrically to balance the other channels during extrusion. Such channel positioning balances the wall thickness and stiffness in the two lateral directions. Finally, the catheter body 176 can include one or more steering wire lumens 200 that extend the entire length of the catheter.

  With reference to FIGS. 4 and 5A, the catheter 130 further includes one or more steering wires 204 that cause the distal end 180 of the catheter 130 to turn in one or more directions. The steering wire 204 is routed by a corresponding number of steering wire lumens 200 and extends from the distal end 180 of the catheter 130 to the proximal end 182 opposite the catheter 130, as described in detail below. Terminate in a suitable way with the steering mechanism. Steering wire 204 is adhesively bonded, heat bonded, crimped, laser welded, resistance welded, soldered or otherwise at a fixed point so that distal movement of the distal end 180 is controlled in a controllable manner by wire movement. It can be connected to the distal tip section 188 of the catheter 130 in a conventional manner such as known techniques. In one embodiment, the steering wire 204 is connected by welding or adhesive bonding to a fluoroscopic marker band (not shown) that is securely attached to the distal tip section. In one embodiment, the band may be held in place by an adhesive and / or an outer sleeve, as will be described in more detail below. The steering wire 204 preferably has sufficient tensile strength and elastic modulus that does not deform (elongate) while being bent and redirected. In one embodiment, the steering wire is made from 0.008 inch diameter 304 stainless steel and has a tensile strength of about 325 KPSI. To improve lubricity and prevent being restrained when the catheter 130 changes orientation, if desired, the steering wire 204 should be housed in a PTFE thin wall extrusion (not shown). Can do.

  In the illustrated embodiment shown in FIG. 5A, the catheter 130 includes two sets of steering wires 204 that controllably manipulate the catheter 130 in two orthogonal planes. In an alternative embodiment, the catheter 130 includes one set of steering wires 204 that allow the user to manipulate the distal tip in one plane. In one embodiment, as will be described in more detail below, the two steering wires are provided and placed on either side of the catheter 130 and are formed into an elongated body 176 or, if included, a sheath or outer sleeve. Unlike the wire lumen 200, it slides in the groove. In a further embodiment, the catheter 130 includes only one steering wire 204 that allows the user to steer the distal tip in one direction. In another embodiment, the steering wire can be omitted, so that the catheter 130 can be of a non-steerable type. In such embodiments, the catheter can be advanced over a pre-positioned guidewire (not shown), eg, in the bile duct or pancreatic duct.

  In one embodiment, the catheter 130 can further include an outer sleeve 208 that wraps the entire length of the elongated body 176, as shown in the cross-sectional view of FIG. The outer sleeve 208 can include one of any number of polymer jackets laminated, coextruded, heat shrink, adhesively bonded or attached onto the catheter body 176. Suitable materials for the sleeve 208 include, but are not limited to, polyethylene, nylon, Pebax® (polyether block amide), polyurethane, polytetrafluoroethylene (PTFE), thermoplastic elastomer, and the like. The outer sleeve 208 can be used to vary the rigid body of the catheter, if desired, or to provide high torque transmission and / or other desirable catheter characteristics. Furthermore, the sleeve 208 can be used as one convenient way to secure the more flexible reorienting section to the proximal section, as described in detail below. In some embodiments, the outer surface of the sleeve 208 can be a hydrophilic coating or a silicon coating to facilitate passage of the device in vivo.

  In another embodiment, the catheter 130 can optionally include an inner reinforcing sheath 210 disposed between the elongated body 176 and the outer sleeve 208. The reinforcing sheath wraps around the entire length of the elongated body 176 or a portion thereof, as illustrated in FIG. 5C. The sheath 210 is like a braided design of fine wire or polymer elements (0.001 inch to 0.010 inch diameter) woven or rolled together along the longitudinal axis of the catheter with conventional catheter braiding techniques. Can be woven or layered. Accordingly, the catheter can be advanced to a desired biological tissue site by increasing the column strength of the assembly while further raising the torsional rigid body of the catheter. Conventional coiled polymer or braided wire is further used for this component with coil wires that are sized in the range of 0.002 to 0.120 inches wide and 0.002 to 0.10 inches thick. be able to. A braided ribbon wire can also be used for the sheath. In one embodiment, the outer sleeve 208 is used to lock the reinforcement layer in place and secure it to the catheter body 176 after the reinforcement layer 210 is applied, as will be described in more detail below. Co-extruded, coated or attached to form a composite catheter.

  FIGS. 6A-6C and FIG. 7 illustrate one suitable embodiment of a catheter 430 constructed in accordance with aspects of the present invention that can be used with the visualization system described above. As best shown in FIG. 6A, the catheter 430 includes a catheter body 476 having a proximal section 482, a turning section 484, and a distal tip section 486. In one embodiment, the proximal section 482 is constructed of a more rigid material than the turning section 484. Proximal section 482 and redirecting section 484 are comprised of suitable materials such as, for example, polyethylene, nylon, Pebax® (polyether block amide), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomers. The extruded part can be made. In one preferred embodiment, the proximal section is a multi-lumen PTFE extrusion about 200 to 220 cm long and the turning section 484 is a multiple tube about 2 to 10 cm long extrusion. Pebax® of the cavity. The redirecting section 484 can be coupled to the proximal section 482 with a suitable adhesive or other techniques. The distal tip section 486 can be coupled to the distal end of the turning section 484 by a suitable adhesive. The distal tip section 486 includes stainless steel or engineering, including but not limited to polyethylene, nylon, Pebax® (polyether block amide), polyurethane, polytetrafluoroethylene (PTFE), and thermoplastic elastomer. It can be made of a suitable material such as plastic. The catheter body 476 can further include a radiopaque marker band 492 that covers a portion of the distal tip section 486.

  The catheter 430 (see FIG. 6B) further includes a reinforcing sheath 488 that extends from the proximal end of the catheter directly to the radiopaque marker band 492 or to the proximal immediately preceding it. The sheath 488 is a braided design of fine wire or polymer elements (0.001 inch to 0.010 inch diameter) that is woven or coiled along the longitudinal axis of the catheter with conventional catheter braiding techniques. Can be a woven or layered structure. Thus, the catheter can be advanced to a desired biological tissue site by raising the column strength of the assembly while raising the torsional rigid body of the catheter. Next, the reinforced catheter body shown in FIG. 6B has one or more sleeve portions 490a having the same or different rigid body values to form the catheter 430, as best shown in FIG. 6C. Wrapped by an outer sleeve 490 that includes 490b and 490c.

  Referring again to FIG. 6A, the catheter 430 further includes a plurality of steering wires 494 that extend past the section 484 turning from the proximal end of the catheter and into the channel of the catheter body. In one embodiment, the steering wire 494 terminates in a radiopaque marker band 492 to which the steering wire 494 is bonded by adhesive bonding, laser welding, resistance welding, soldering, or other known techniques. In this embodiment, the catheter body includes an opening 495 formed in its outer surface just proximal to the radiopaque marker band 492 by a suitable method such as skiving. As shown, the opening 495 communicates with the steering wire channel so that the steering wire 494 can exit the extruded catheter body and connect to the radiopaque marker band 492.

  In some instances where the catheter body is not extruded or constructed of PTFE or other friction reducing material, the steering wire 494 is free to move within the catheter body, and particularly within the turning section 484. In other words, it may be desirable to wrap the steering wire 494 in a laminated structure 496 so that the mechanical movement of actuation is as smooth as possible. As best shown in FIG. 7, the laminated structure 496 includes an internal reinforcement member 498 such as a metal braid (eg, a stainless steel braid wound in a 0.0015 "x 0.006" spiral). Formed by an outer jacket 497 made of a thermoplastic polymer such as encapsulating polyurethane, Pebax®, thermoplastic elastomer. Within the reinforcing member 498 is a layer 499 of friction reducing material, such as PTFE or FEP tubing, on which the above layer is formed. In embodiments where the proximal section 482 is extruded or formed of a friction reducing material, the laminated structure 496 includes a proximal section 482 and an orienting section 484 as best shown in FIG. 6A. Starting from the intersection, it extends to the nearest radiopaque marker band 492.

  According to one embodiment of the present invention, the multi-lumen catheter described herein can be extruded using known materials such as PTFE, nylon, Pebax®, and the like. The catheter can be extruded using a mandrel. In some embodiments of the invention, the mandrel can be composed of a suitable material such as stainless steel, PTFE coated stainless steel, or phenolic plastics such as Cellcore®. As shown in the embodiment of FIG. 5A, the multi-lumen catheter 130 includes a working channel 192, a fiberscope or observation device channel 194, and four smaller steering wire lumens 200 spaced 90 degrees apart. Including 8 lumens. In order to balance the lateral wall thickness and rigid body during extrusion, the left and right lumens 196, 198 can also be formed using separate mandrels. These lumens 196, 198 can be used for air / gas flushing and infusion.

  The catheter 130 shown in FIG. 5B can optionally include an outer sleeve 208. The sleeve can be constructed of a suitable material by reflow or coextrusion such as spray coating, heat shrink processing. The outer sleeve 208 can provide additional rigidity, improved torque transmission, and the like. In one embodiment, an outer sleeve can be applied to facilitate the connection of a flexible distal section, such as a section that turns to a lower durometer value than the rest of the catheter body. In such embodiments, one suitable material that can be used includes, but is not limited to, Pebax® (polyether block amide). In another embodiment, the catheter 130 can include a reinforcing layer 210 or sheath between the catheter body 176 and the outer sleeve 208, as best shown in FIG. 5C. The reinforcement can be a known catheter reinforcement structure such as a wire coil or braid. In such embodiments, once the reinforcing layer 210 is applied, the outer sleeve 208 is coextruded, coated, or connected to lock the reinforcing layer in place. It will be appreciated that the reinforcing layer 210 can extend the entire length of the catheter or a portion thereof. In one embodiment, the reinforcing layer 210 extends over the section that turns. It will be appreciated that when the body is extruded from PTFE, its outer surface should be etched or treated for proper bonding with the outer layer.

According to another embodiment, as best shown in FIGS. 8A-8C, a catheter can be constructed using a catheter core 520, an optional reinforcing layer 524, and an outer sheath or jacket 526. The catheter core 520, nylon with a mandrel, PTFE, Pebax ^(registered trademark) is an open lumen core from a suitable material is extruded such. In this embodiment, a mandrel (not shown) is arranged and configured to create a plurality of open lumens 592, 594, 596, 598, and 599 during extrusion. The mandrel can be composed of metal, Cellcore®, or PTFE. When the open lumen core is extruded, the mandrel is held in position and the center is co-extruded to add an outer sleeve 526, as shown in FIG. As well shown, it is coextruded to add a reinforcing layer 524 and an outer sleeve 526. As described above, the outer sleeve 526 functions to facilitate locking of the position of the braid and / or the connection of a distal section, such as a turning section having a lower rigid body value, if desired. can do.

  The mandrel (not shown) can then be removed after coextrusion. In one embodiment, the mandrel is comprised of a phenolic plastic such as Cellcore®. To remove such a mandrel, the mandrel is pulled from one end or both ends. Due to the “neck-down” effect inherent in Cellcore® material, the cross-sectional area of the mandrel becomes smaller when in tension and in tension, allowing the mandrel to be removed from the assembly catheter. In one embodiment, this property of Cellcore (R) can be exploited to benefit manufacturers by using such materials for steering wire lumen mandrels. However, instead of completely removing the mandrel from the steering wire lumen, it is possible to tension the steering wire mandrel and pull the mandrel to a reduced diameter sufficient to function as a steering wire. Thus, for use as a steering wire, this pulled mandrel is then connected to the distal end of the catheter in a conventional manner. Although the latter embodiment has been described as being coextruded to form an outer sheath, the outer sheath can be formed on the catheter core by heat shrink processing or spray coating.

  It will be appreciated that not all lumens of the latter embodiment need be formed as open lumens. Thus, as best shown in FIGS. 9A-9C, only the steering wire lumen 699 is formed as an open lumen. This creates an oversized lumen for the steering wire and provides the largest possible lumen diameter for lumens 692, 694, 696, and 698.

  As described above, in some embodiments of the catheter, it is desirable that the turning section be configured to deflect more easily than the proximal portion. In one embodiment, the turning section has a lower durometer value than the proximal portion. In another embodiment, the flexibility can be gradually (eg, increased) throughout the length of the catheter tube from its proximal end to its distal end. In another embodiment, the section to change direction can be an articulation section. For example, the section that turns may include a plurality of segments that can turn the distal section in one or more directions. See, for example, co-pending U.S. Patent Application Nos. 10 / 406,149, 10 / 811,781, and 10 / 956,007 for examples of articulation sections in which the present invention can be implemented. (The disclosure is incorporated herein by reference).

  Referring again to FIGS. 3 and 4, the catheter 130 is operatively connected to the catheter handle 132. The handle 132 includes a handle housing 220 to which a steering mechanism 224, one or more ports 226, 228, 230, and an endoscope connection device 234 are operatively connected. In one embodiment, the handle housing by two housing halves 220a and 220b joined by a suitable removable fastener such as a screw or a non-removable fastener such as a rivet, snap, thermal bond or adhesive bond. 220 is formed. In the illustrated embodiment, as best shown in FIGS. 4 and 15, the proximal end of the catheter 130 is routed through a strain relief joint 238 that is secured to the distal end of the handle housing 220. And terminate at the Y connector 242. The Y connector 242 can be secured to the handle housing 220 by suitable means such as bonding with an adhesive. Similarly, the proximal end of catheter 130 is securely coupled to Y connector 242 by any suitable means known in the art, such as adhesive bonding. Y connector 242 defines passages 248 and 250 that communicate with the catheter working channel and catheter imaging device channel, respectively, by openings 251 and 252 located on the outer surface of the catheter, as best shown in FIG. First and second branch joints 244 and 246 are included.

  In embodiments of the present invention, the openings 251 and 252 can be formed by skiving the outer surface of the catheter. This process can be done manually using known mechanical techniques or by laser micromachining to remove local areas of material from the outer surface of the catheter to expose one or more catheter channels. Upon assembly, the proximal end of the catheter channel is capped with an adhesive, or the proximal end of the catheter is capped to prevent access to the channel.

  As described above, the handle housing 220 includes one or more ports 226, 228, 230 for providing access to each channel of the catheter 130. In the illustrated embodiment, the ports include, but are not limited to, working channel port 226, imaging device port 228, and wash / intake port 230. The port can be defined by a suitable structure. For example, working channel port 226 and imaging device port 228 can be defined by joints 254 and 256, respectively, that can be coupled or secured to handle housing 220 during assembly. In one embodiment, the housing halves can define a striking structure that securely locks the fittings 254 and 256 in place when assembled. For the flush / intake port 230, a luer fitting 258 is preferably used to define the port 230. Fitting 258 defines a passage 260 for fluidly connecting port 230 to the appropriate catheter channel, as best shown in FIG. Fitting 258 functions with barrel connector 264 that seats catheter 130. The barrel connector 264 defines a cavity 266 that surrounds the periphery of the catheter 130 and is fluidly connected to an appropriate catheter channel (cleaning channel) by an inlet 270. As such, port 230 is connected in fluid that communicates with the wash channel by passage 260 and cavity 266. In one embodiment, the inlet 270 is formed by skiving the outer surface of the catheter. This process can be performed manually using known mechanical techniques or by laser micromachining to remove localized areas of material from the outer surface of the catheter to expose one or more catheter channels. it can. Working channel port 226 and imaging device port 228 are connected in communication with branch joints 254 and 256 of the Y connector via appropriate tubing 272, respectively, and are best shown in FIG.

  The catheter handle 132 further includes a steering mechanism 224. The steering mechanism 224 of the catheter handle 132 controls the change in orientation of the distal end 180 of the catheter 130. The steering mechanism 224 can be a known or future developed mechanism that can cause the distal end of the catheter to change orientation by selectively pulling the steering wire. In the embodiment illustrated in FIGS. 3 and 4, the steering mechanism 224 includes two rotatable knobs that provide four-way steering of the catheter distal end in the up / down and right / left directions. The mechanism 224 includes an outer knob 280 for controlling up / down steering and an inner knob 284 for controlling right / left steering. Alternatively, the inner knob 284 can function to control right / left steering and the outer knob 280 can function to control up / down steering. The knobs are connected to the distal end of the catheter 130 by steering wires 204 that each extend through the catheter 130. Although a manually operated steering mechanism for providing distal four-way steering is shown, two-way steering is within the scope of the present invention because a manually operated steering mechanism for providing two-way steering can be implemented. It will be understood that it is interpreted as being within.

  Referring now to FIG. 12, one embodiment of a steering mechanism 224 that can be implemented with the present invention is shown. The steering mechanism 224 includes inner and outer pulleys 288 and 290 and control knobs 280 and 284. An inner pulley 288 for left and right bend control is mounted through an internal bore 294 to rotate on the shaft 296, which shaft 296 is integrally formed or fixed from the housing half 220a. And is positioned to extend into the handle housing 220. Inner pulley 288 is integrally formed or fixed for rotation with one end of internal rotation shaft 300. The opposite end of the inner rotating shaft 300 extends out of the handle housing 220 to which the control knob 280 is attached for co-rotation. In one embodiment, the end 304 of the inner rotating shaft 300 is configured to be secured with a control knob opening that is operatively configured. The control knob 280 can then be held there by a screw fastener. The proximal end of one set of steering wires 204 is connected to both sides of the inner pulley 288 in a conventional manner.

  An outer pulley 290 for upper and lower bending control is rotatably fitted on the inner rotating shaft 300 for independent rotation with respect to the inner pulley 288. To rotate with one end of the outer rotating shaft 310, the outer pulley 290 is integrally formed or fixed. The outer rotating shaft 310 is arranged concentrically so as to rotate on the inner rotating shaft 300. The opposite end of the outer rotating shaft 310 extends out of the handle housing 220 to which the control knob 284 is attached for co-rotation. The rotating shafts 300, 310 are further supported for rotation within the housing 220 by bosses 316 that are integrally formed or positioned to extend inwardly from the housing half 220 b to the handle housing 220. Has been. It will be appreciated that other structures for rotatably supporting the pulleys 288, 290 and the shafts 300, 310 within the handle housing 220 may be provided. When assembled, the proximal ends of the second set of steering wires 204 are each fixedly connected to the outer pulley 290 in a conventional manner.

  In one embodiment, a thrust plate 320 is disposed between the inner and outer pulleys 288, 290 to isolate rotational movement therebetween. When the thrust plate 320 is assembled in the housing 220, its rotation is limited.

  The steering mechanism 224 can further include a locking mechanism 340 that, in use, functions to lock the catheter 130 in a desired orientation position. The locking mechanism 340 includes a lever 344 operable between a locked position and a locked release position. In the embodiment illustrated in FIG. 10, a detent 346 is provided and can be molded to the outer housing half 220b to provide constant spacing between the locked and unlocked positions. Small bumps (not shown) can be included to inform the user that the position of lever 344 has changed.

  Referring now to FIGS. 12, 13A, and 13B, the locking mechanism 340 further includes a lever member 350 and a pulley member 354 that are housed within the handle housing 220 when assembled. The lever member 350 includes a through-hole 358 that is sized and configured to receive the outer rotating shaft 310 for rotational support. When assembled, the lever member 350 includes a boss section 362 that is sized and configured to be rotationally supported by extending the boss 316 inwardly. The boss section 362 is configured to be fixed at one end 364 to rotate with one end of the locking lever 344. The lever member 350 further includes a flange 366 that is integrally formed on the other side of the boss section 362. The end face 368 of the flange 366 defines a cam profile extending annularly around the flange 366. In the illustrated embodiment, the cam profile is formed by varying the flange thickness. The pulley member 354 includes a boss section 370 that is sized and configured to receive its lever member 350. The pulley member 354 includes an inwardly extending flange 374 that defines the cam profile of the lever member facing the surface 378 of the flange 374. Similar to the lever member 350, the cam profile of the pulley member 354 is formed by varying the thickness of the annularly extending flange. The inwardly extending flange 374 further defines a through-hole 380 that is sized and configured to receive the outer rotating shaft 310 for rotational support. When assembled, the pulley member 354 can be translated linearly, although limited in rotation relative to the housing 220, as described in more detail below.

  During assembly, the lever member 350 is inserted into the pulley member 354, the cam contours engage, and the lever 344 is secured to the lever member 350 for rotation. The cam profile of lever member 350 and pulley member 354 is specifically configured to transmit the rotational movement of lever 344 to the translational movement of pulley member 354. Thus, when the lever member 350 is rotated by moving the lever 344 from the unlocked position to the locked position, the pulley member 354 is linearly separated from the lever member 350 by the cooperation of the cam profile. Moving. Therefore, the lever member 350 functions as a cam, and the pulley member 354 functions as a follower that converts the rotational motion of the lever 344 into the linear motion of the pulley member. Due to the linear motion of the pulley member 354, the inner pulley 288 frictionally engages the housing 220 and the thrust plate 320, while the outer pulley 290 frictionally engages the thrust plate on one side and the pulley member on the other side. To do. Because the friction present between the mating surfaces prevents rotation of the inner and outer pulleys 288 and 290, the distal end of the catheter is fixed in a reoriented position.

  To change the change in orientation of the distal end of the catheter from one position to another, the locking lever 344 is moved from the locked position to the unlocked position. This in turn causes the lever member 350 to rotate relative to the pulley member 354. Due to the cam profile configuration of the lever and pulley member, the pulley member 354 can move toward the lever member 350. This alleviates the friction between the surface engagements and allows the inner and outer pulleys 288 and 290 to rotate by turning the control knobs 284 and 280.

  In accordance with aspects of the present invention, the catheter assembly 128 can be mounted directly on the endoscope handle 140 so that a single user can operate both the endoscope 124 and the catheter assembly 128 using both hands. In the illustrated embodiment, the catheter handle 132 is attached to the endoscope 124 by an endoscope attachment device such as a strap 234. The strap 234 can be wrapped around the endoscope handle 140 as best shown in FIG. The strap 234 includes a number of notches 366 into which the head of the housing protrusion 368 is selectively inserted to couple the catheter handle to the endoscope, as best shown in FIG. Strap 234 allows catheter handle 132 to rotate about the shaft of endoscope 124, if desired. The strap 234 is positioned so that the longitudinal axes of both handles are substantially aligned when used to connect the handle 132 to the endoscope 124, as best shown in FIG. In addition, the orientation of the strap and the position of the port on the catheter handle 132 allows for the manipulation of diagnostic or therapeutic devices and viewing devices through the catheter without interfering with endoscope control and utilization. As a result of connecting the catheter assembly 128 directly to the endoscope 124, the catheter 130 creates a loop known as the service loop before entering the biopsy port 172, as illustrated in FIG. In one embodiment, the catheter includes a proximally located stop sleeve or collar (not shown) that limits the extension of the catheter 130 beyond the minimum diameter of the service loop and the distal end of a conventional endoscope. be able to. Alternatively, the catheter 130 can be marked or marked and used to prevent over insertion of the catheter 130.

  In embodiments of the present invention in which a service loop is formed by connecting the catheter handle 132 directly to the endoscope 124, the catheter 130 is preferably suitably longer than a conventional catheter to make up for the service loop. Consists of. In some such embodiments, the catheter handle 132 is preferably mounted under the biopsy port 172 of the endoscope 124 and the catheter 130 is preferably looped up and into the biopsy port 172. Is done. In this configuration, the catheter 130 is accessible and can be grasped by the user just above the biopsy port for catheter insertion, withdrawal, and / or rotation.

  While the above embodiment shows a handle connected below the biopsy port and oriented longitudinally with respect to the catheter, other configurations are possible. For example, the handle can be associated with the endoscope such that the longitudinal axis of the catheter handle is generally transverse to the longitudinal axis of the endoscope handle. In addition, the catheter handle can be mounted proximally or distally to the biopsy port and can be mounted directly on the biopsy port such that the longitudinal axis of the catheter is coaxial with the biopsy port. . Examples of such alternative configurations are described in more detail below with respect to FIGS. 20-22 and 31-34.

  As briefly described above, a small diameter viewing device, such as a fiberscope or other imaging device, is slid to its distal end by one channel (eg, imaging device channel) of catheter 130 (FIG. 3). Can be sent movably. The viewing device allows a user of the catheter assembly to view the object at or near the distal end or tip of the catheter. For a detailed description of one suitable embodiment of an observation device that can be utilized by the visualization system, see the observation device described in FIG. 35 below. Other examples of observation devices that can be implemented with embodiments of the present invention are described in co-pending US patent application Ser. No. 10 / 914,411, and US Patent Application Publication No. 2004/0034311 A1. See the description of the guidewire scope described (the disclosure of which is incorporated herein by reference).

Referring now to FIG. 35, a suitable embodiment of a viewing device 1870, such as a fiberscope or other imaging device, formed in accordance with an aspect of the present invention is shown. As briefly described above, the viewing device 1870 can be slidably delivered to its distal end by one channel of the catheter 130 (eg, a viewing device or an imaging device channel). Viewing device 1870 allows the user of the catheter assembly to observe objects at or near the distal end or tip of the catheter.
The viewing device 1870 includes a fiber optic cable 1972 connected to an optical handle 1974. Fiber optic cable 1972 is defined, for example, by one or more optical fibers or bundles 1882 and 1884 wrapped in a cylindrical, elongate tubular sleeve 1886. The outer diameter of the fiber optic cable 1972 is preferably 0.4 mm to 1.2 mm, although other sizes may be used depending on the application and size of the catheter channel. The tubular sleeve 1886 of the fiber optic cable 1972 can be constructed of a suitable material such as, for example, nylon, polyurethane, polyether block amide. Furthermore, metallic hypotubes can also be used.

  In the illustrated embodiment, the fiber optic cable 1972 includes one or more centrally extending coherent video fibers or fiber bundles 1884 and one or more image fibers generally surrounding one or more image fibers of the fiber bundle 1884. Irradiating fibers or fiber bundles 1882 extending in the circumferential direction (which may not be coherent). The fibers or fiber bundles 1882 and 1884 can be attached to the tubular sleeve 1886 by a suitable adhesive. The distal end of the fiber optic cable 1972 includes a window (not shown) that wraps around the distal end to protect the distal lens and / or fiber bundle.

  The proximal end of fiber optic cable 1972 functionally connects to handle 1974. In use, the illumination fiber or fiber bundle 1882 illuminates the area or object to be viewed, while the video fiber or fiber bundle 1884 allows the user to observe the image transmitted by the image fiber or fiber bundle 1884. The irradiated image is sent to an image viewing device, such as an eyepiece or eyepiece lens device 1880 that can. The optical handle 1974 can be further configured to connect to a camera or imaging system so that a user can store an image and view it on a display. It will be appreciated that the handle 1974 can include other known components such as an adjustment knob (not shown) that adjusts the relative position of the lenses so that the focus of the image transmitted through them can be adjusted. Let's be done. Handle 1974 further includes a light post 1888 connected to the proximal end of the illumination fiber or fiber bundle 1882. The optical post 1888 is configured to releasably connect to an optical cable for supplying light from a light source outside the viewing device 1870 to the illumination fiber or fiber bundle 1882.

  The viewing device 1870 can have a stop collar or sleeve (not shown) to limit the movement of the cable 1972 through the viewing device channel of the catheter so that the cable 1972 can extend beyond the distal end of the catheter 130. The length can be limited. The inner surface of the viewing channel of the catheter may have color markings or other scale means to indicate to the user that the end of the catheter is approaching or has reached the end when the cable 1972 is inserted. it can.

  One suitable method of operating the in-vivo visualization system 120 will now be described in detail with reference to the above figures. The insertion tube 142 of the endoscope 124 first passes through the patient's esophagus under visualization by the endoscope. The insertion tube 142 of the endoscope 124 is advanced through the stomach and into the duodenum at the bottom of the stomach. The biliary system includes the gallbladder duct from the gallbladder, the hepatic duct from the liver and the pancreatic duct from the pancreas. Each of these tubes is connected to the common bile duct. The common bile duct intersects the duodenum just below the stomach. The nipple controls the size of the opening at the intersection between the bile duct and the duodenum.

  In order to reach the bile duct to perform a hepatic duct procedure, it is necessary to cross the nipple. The insertion tube 142 of the endoscope 124 is operated under direct visualization so that the exit port of the working channel 150 is beyond the nipple or so that the port is slightly below the nipple. After positioning the distal end of the insertion tube 142 in a suitable position, the catheter 130 with the observation device 1870 is operated in the endoscope 124 so that the distal end of the catheter 130 emerges from the endoscope and enters the nipple. Channel 150 can be advanced. When the endoscope 124 emerges from the endoscope 124 and is advanced to enter the nipple, observation through the catheter is provided. After entering the nipple, the catheter 130 can be advanced into the common bile duct. Proceeding into the common bile duct, the fiber optic cable 1972 of the viewing device 1870 disposed within the catheter 130 allows the surgeon to observe tissue within the bile duct for diagnosis and / or treatment.

  Alternatively, when the insertion tube 142 of the endoscope 124 is placed in place next to the nipple, the conventional guidewire and sphincter are advanced together through the endoscope and through the nipple common bile duct. Can enter the common bile duct and pancreatic duct. In order to enlarge the nipple, the surgeon may need to use a sphincterotome. The sphincterotome can then be removed from the patient while leaving the conventional guidewire in place. The catheter 130 and the fiber optic cable 1972 of the viewing device 1870 can then be advanced together over a conventional guidewire, through the papilla and into the common bile duct. Once in the common bile duct, the fiber optic cable 1972 of the viewing device 1870 allows the surgeon to observe tissue within the bile duct for diagnosis and / or treatment.

  It will be appreciated that the choice of material in the catheter and the use of insertable and removable optics allows the catheter to be configured as a disposable device. Once the procedure is performed, the catheter can be removed from the endoscope and discarded, while the optical device can be removed and sterilized for reuse.

  Although steerable catheter assembly 128 has been described above for use with an endoscope, the catheter assembly can be used with other devices or can be used alone or with observation device 1870. Will be understood.

  Referring again to FIGS. 16A-16B, front and rear perspective views, respectively, of an alternative embodiment of a catheter assembly 728 formed with aspects of the present invention are shown. The catheter assembly 728 is utilized by the visualization system 120 shown in FIG. 1 instead of the assembly 128, as desired, or used independently of the system 120 of FIG. 1 or with other medical devices. be able to. In this embodiment, the catheter assembly 728 includes an elongated catheter 730 and a control handle 732.

  As best shown in FIG. 16A, the catheter 730 includes a proximal section 742 that extends along most of the catheter 730 and a shorter distal section 746. Proximal section 742 has a higher durometer or rigid body than distal section 746 so that distal section 746 turns more easily than proximal section 742. Alternatively, instead of or in conjunction with the lower durometer distal section, the catheter 730 is articulated section or joint that is coupled to the end of the proximal section to more easily turn compared to the proximal section. Can be included. Some examples of articulation sections or joints that can be performed with embodiments of the catheter 730 are described above with respect to the catheter 130. Catheter 730 is made of Pebax® (polyether block amide), nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane, fluorinated ethylene propylene (FEP), thermoplastic elastomer, or the like, or combinations thereof It can be constructed in part or in whole from suitable materials. In some embodiments, the catheter 730 can be configured according to one or more aspects of the catheter 130 described above with respect to FIGS. 3 and 5A-5C. In one embodiment, the catheter 730 has an outer diameter between about 5 and 12 French.

  Catheter 730 defines one or more channels 748 that extend from its proximal end (not shown) to its distal end 752. In the end view of the catheter 730 shown in FIG. 16C, one or more channels 748 of the catheter 730 include a steering device channel 748a and, for example, a working channel 748b and a fiberscope or other observation device channel 748c. As shown, other configurations are possible, but the steering device channel 748a is slightly offset from the longitudinal axis of the catheter. It will be appreciated that the catheter 730 can be configured with other channels (not shown), such as a wash / infusion channel. Furthermore, it will be appreciated that the catheter 730 may omit one or more of the above-described channels if desired.

  Referring again to FIGS. 16A-16B, the control handle 732 is operatively connected at its distal end to the proximal end of the catheter 730. The control handle 732 includes a handle housing 768 having one or more ports, such as a working channel port 756 and an observation device port 758 (see FIG. 16B). Ports 756 and 758 are configured to access one or more of a plurality of channels 748 defined by catheter 730, such as working channel 748b and viewing device channel 748c, respectively. Control handle 732 can include a manifold and associated structure, such as a flexible conduit, for interconnecting with ports and catheter channels. For example, in one embodiment, a manifold such as a flexible conduit is configured substantially similar to the Y connector described above with respect to FIG.

The control handle 732 further includes a steering mechanism 774 for controlling the change in orientation of the distal end 752 of the catheter 730. In the embodiment shown in FIGS. 16A-16C, the steering mechanism 774 includes an elongated wire or stylet 776 and a knob 784. An opening 780 is provided at the proximal end of the handle housing 768. The opening 780 is connected in communication with the steering device channel 748a of the catheter 730, for example, via a passage defined by the handle housing 768. Opening 780, passageway, and steering device channel 748 are configured such that passage of stylet 776 is slidable and pivotable through control handle 732 and catheter 730. A knob 784 is connected to the proximal end of the stylet 776 and can be utilized to control the movement of the stylet relative to the handle housing 768, as described in detail below.
The stylet 776 can have many configurations to control the change in orientation of the distal end 752 of the catheter 730. FIG. 17A shows a partial view of one exemplary embodiment of a stylet 776a that can be implemented in accordance with embodiments of the present invention. In this embodiment, the stylet 776a is a shaped wire made of a material that exhibits non-linear or linear superelastic properties. An example of a material that exhibits non-linear or linear superelastic properties that can be implemented in embodiments of the present invention is a nickel titanium alloy such as Nitinol®. In the illustrated embodiment, the shaped shape of stylet 776a includes a curved distal end region 788a, as best shown in FIG. 17A. Although the curved distal end region 788a is shown as somewhat arcuate, it will be appreciated that the curved distal end region 788a of the stylet 776a can be formed in an arcuate and / or linear orientation, depending on the procedure being performed. The stylet 776a can be provided with a control handle 732 or can be sold separately as one of a set of pre-formed stylets, each having a different pre-formed profile.

  In one embodiment, the curved distal end region 788a of the stylet 776a can be created by constraining the stylet 776a in a desired shape and heating the wire to about 500 ° C. for a suitable period of time, such as 10 minutes. The stylet 776a is then left to cool. After cooling, the stylet 776a retains the preformed distal end region shape. The stylet 776a can then be stressed to change its shape. For example, a stretching force is applied to the preformed distal end region 788a of the stylet 776a such that the stylet 776a is introduced at the proximal end of the catheter 132. Such stress on the stylet 776a creates an internal force on the stylet, hereinafter referred to as a restoring force herein. When the stretching force due to the superelasticity of the stylet 776a is removed, the recovery force generated with the stylet 776a causes the stylet 776a to return to its original preformed shape, as described in detail below. And recover.

  In an embodiment of the invention, as best shown in FIG. 17B, the stylet 776a is stretched so that it does not return to its preformed shape when the proximal section 742 of the catheter 730 is positioned there. It will be appreciated that the material, configuration, and dimensions of both the catheter 730 and the stylet 776a can be selected to provide an appropriate restraining force (e.g., stretching force) for the closed stylet. Further, as best shown in FIG. 17C, the stylet 776a's recovery force (triggered when the stylet is stretched and maintained while positioned proximally) is located there. It is understood that the material, configuration, and dimensions of the catheter can be selected to exceed the rigid body of the distal section 746 of the catheter 730 and change the orientation of the catheter 730 according to its preformed shape when being Like.

  Once assembled, the change in orientation of the distal end 752 of the catheter 730 can be controlled by the knob 784. Advancement of the knob 784 toward the control handle 732 causes the pre-formed stylet 776 to move from the more rigid proximal section 742 of the catheter 730 shown in FIG. 17A to the more flexible shown in FIG. 17C. Advance to distal section 746. This advancement causes the distal end 752 of the catheter 730 to turn by the preformed curved distal end region 788a of the stylet 776a, as best shown in FIG. 17C. By translating the knob 784 away from the control handle 732, the distal end 752 of the catheter returns to its intermediate position (eg, a configuration in which the catheter has not changed orientation), which in turn is illustrated in FIG. 17B. As such, the curved distal end region 788 a of the stylet 776 a is drawn from the flexible distal section 746 to the proximal section 742. To turn the distal end 730 of the catheter in another direction, the knob 784 is rotated clockwise or counterclockwise to the desired position before the stylet 776a is advanced to the catheter distal section 746. . To that end, it will be appreciated that a stylet having high torque characteristics for rotating the stylet 776a within the catheter 730 can be constructed. Thus, the distal end 752 of the catheter 730 can be turned in any direction relative to the longitudinal axis of the catheter. It will be appreciated that other mechanisms for advancing and reversing the stylet can be used, such as a thumb slide or thumb wheel.

  FIG. 18A shows a partial view of another exemplary embodiment of a stylet 776b that can be implemented in accordance with embodiments of the present invention. In this embodiment, the stylet 776b can be composed of a shape memory material. The shape memory material preferably exhibits memory characteristics with respect to changes in conditions such as temperature. In the illustrated embodiment, the shape memory material is a mechanical memory alloy such as a nickel titanium alloy. One nickel titanium alloy that can be implemented with one embodiment of the present invention is commercially available under the trademark Nitinol®. The shape memory material has a first physical attribute, such as a shape in a first condition, such as a first temperature, and a second physical attribute, such as a different shape in a second condition, such as a higher temperature. Can be configured. For example, the stylet 776b has a first shape at a first temperature (eg, a straight configuration best shown in FIG. 18A) and a second shape when heated to a second higher temperature. (E.g., a configuration having a curved distal end region, best shown in FIG. 18B). While a nickel titanium alloy is desirable for the stylet 776b construction, other materials having memory properties with respect to temperature or other conditions may be used without departing from the scope of the present invention.

  In an embodiment where a shape memory alloy such as nickel titanium is used to construct the stylet 776b, in one example shown, for example, in FIG. That is, it can be tempered to the second shape). For example, to allow introduction into the catheter 730, the stylet 776b can be cooled and stretched to its first shape shown in FIG. 18A. In use, heating the stylet 776b again to a predetermined transition (also known as transformation) temperature or higher returns the stylet 776b to its pre-formed shape shown in FIG. 18B. As such, in this embodiment, the stylet 776b can be referred to as a temperature-actuated stylet. In the illustrated embodiment, the predetermined transition temperature can be any temperature above body temperature. For example, the predetermined transition temperature can be in the range of about 100 ° to 150 ° F. In another embodiment, the transition temperature of stylet 776b may be close to, but less than, normal patient body temperature. In either case, the stylet 776b is manufactured to obtain the desired configuration when the temperature of the stylet 776b reaches the transition temperature.

  In this embodiment, the control handle 732 is further from a position outside the body to cause the distal end 752 of the catheter 730 to turn in at least one desired direction corresponding to the preformed shape of the stylet 776b. A stylet heating system (not shown for convenience of illustration) can be included to increase the temperature of the stylet 776b. In one embodiment, the stylet heating system includes a heating device connected in electrical communication with a power supply. A heating device is disposed in the control handle in heat transfer relationship with the stylet. In one embodiment, the heating device may be a positive thermal coefficient (PTC) heating element that heats when power is supplied thereto. The power can be AC or DC and can be supplied to the control handle by a power cord or provided in the control handle as a power storage source such as a battery. The stylet heating system further includes a control device such as a switch for selectively supplying power to the heating device. It will also be appreciated that various other types of control devices may be utilized without departing from the scope of the present invention.

  In use, the stylet 776b is first brought to a temperature below its transition temperature (ie, in its first straight configuration shown in FIGS. 18A and 18C) to change the orientation of the distal end 752 of the catheter 730. To the distal end 752 of the catheter 730. The control switch is then activated, thereby supplying power to the heating device. When the heating device receives power from the power source, the heating device raises the temperature and transfers the heat to the stylet 776b. As the stylet 776b temperature rises above the transition temperature, the stylet 776b retains its pre-formed shape and turns the distal end 752 of the catheter 730 to the changed catheter orientation shown in FIG. 18D. Let me. To return the catheter 730 to its intermediate (ie, unoriented) configuration shown in FIG. 18C, the heating device is not powered by returning the control switch to its “off” position. .

  Thus, the stylet 776b returns to its first temperature that is lower than its transition temperature. As the stylet 776b falls below its transition temperature, the stylet 776b extends to its non-curved position, which in turn extends the catheter 730 to the unchanged orientation shown in FIG. 18C.

  FIG. 19A shows a partial view of another example embodiment stylet 776c that can be implemented in accordance with embodiments of the present invention. The stylet 776c is substantially similar to the stylet 776a in configuration and operation, except for the differences described in detail below. In this embodiment, the stylet 776c can be composed of stainless steel or other suitable biocompatible material that allows it to be “excessively curved” for a given shape. This overcurvation solves problems associated with conventional materials such as stainless steel that typically occur when the stylet is stretched for introduction. Typically, materials that can be “overcurved” have such an elastic limit of less than about 2% and cannot be returned to their preformed shape after being stretched for introduction. Or other materials. Thus, in this embodiment, as illustrated in FIG. 19A, the catheter 730 can be turned into the desired shape when introduced into the distal section of the catheter that can be turned. The shape of the stylet distal end region 788c is exaggerated or “overcurved”. For example, the curved distal region 788c of the stylet 776c can obtain an angle [alpha] of "overcurve" orientation of about 40 degrees, as illustrated in FIG. 19A. When stretched, introduced into the catheter, and sent to the end of the catheter, the stylet 776c returns to an angle β that is less than the angle α in the “overcurved” direction, as illustrated in FIG. 19B.

  One exemplary method of utilizing the catheter assembly 728 is now described in detail. Prior to introducing the catheter into the patient, one of the stylets 776a, 776b, or 776c can be loaded through the opening 780 into the control handle 732 and advanced into the steering device channel of the catheter 730. In one embodiment utilizing stylet 776a or 776c, first its curved distal end region 788 is stretched against the recovery force generated by the material properties of the stylet, and then the stretched stylet is distal to catheter 730. By proceeding to section 742, the stylet is mounted. In embodiments using stylet 776b, the stylet advances to the distal end 752 of catheter 730. The catheter 730 can then be advanced through the patient's selected passage by moving the control handle 732 to reach the desired in-vivo position. The catheter 730 can be advanced by itself or through the working channel of the endoscope. In embodiments using a catheter assembly with an endoscope, the control handle 732 is moved forward relative to the biopsy port of the endoscope to advance the catheter 730.

  As the catheter 730 advances through the passageway, it may be desirable to change the orientation of the distal end 752 of the catheter 730 to help position and advance the catheter to the desired in-vivo location. To that end, in embodiments of the invention that utilize stylet 776a or 776c to change the orientation of distal end 752 of catheter 730, the stylet distal end region 788 is more distal than catheter 730. The stylet is advanced by moving the knob 784 toward the handle 732 until it reaches the flexible section 746. When the stylet reaches the distal section 746, the stylet's restoring force exceeds the restraining force of the distal section 746, so that the distal end region of the stylet is restored to its preformed configuration, thereby Reorient the distal section of catheter 730 to the desired configuration. It will be appreciated that the distance that the stylet has advanced within the distal section 746 of the catheter 730 allows the user to vary the magnitude of the orientation change.

  In embodiments that utilize stylet 776b, distal end 752 of catheter 730 is turned by activating stylet 776b. In order to activate the stylet 776b, the temperature of the stylet is increased by, for example, a heating device capable of heating the stylet. As the stylet 776b temperature rises above its transition temperature, the stylet 776b retains its pre-formed shape and causes the distal end 746 of the catheter 730 to turn to its desired configuration.

  As the catheter 730 turns in the desired direction, the catheter 730 further advances to the desired passage. After the catheter 730 enters the desired passage, it may be desirable to return the distal end 752 of the catheter 730 to a configuration that has not changed its middle or orientation. To that end, in embodiments utilizing stylet 776a or 776c, the stylet is such that the curved distal end region 788a of stylet 776a moves from flexible distal section 746 to proximal section 742. The knob 784 is retracted by translating it away from the control handle 732. Alternatively, in embodiments utilizing stylet 776B, the power supply to the heating device is turned off by placing the control switch in its “off” position. Thus, the stylet 776b returns to its first temperature that is below its transition temperature. When the stylet 776b is below its transition temperature, the stylet 776b extends to its uncurved configuration and then the catheter is in its neutral (ie, unoriented position) shown in FIG. 18C. Stretch out. It will be appreciated that when the catheter is routed, the body of the catheter 730 can have a general curvature, and therefore the neutral configuration of the catheter is intended to include such a general curvature. .

  The distal end 752 of the catheter 730 can then be alternately turned and stretched so that the catheter 730 can be advanced to its desired in-vivo location. In embodiments where it is desirable to change the orientation of the distal end of the catheter 730 in a direction different from the previous orientation, the stylets 776a-776c are in the appropriate positions for the stylet to turn the catheter in the desired direction. It can be rotated in the steering device channel until When the catheter 730 reaches its desired in-vivo location, the fitting and / or viewing device can be routed through each catheter channel as desired. Alternatively, the observation device 1870 can be sent through the catheter 730 before or during advancement of the catheter to assist in-vivo movement within the patient's passage.

  In an alternative method, the stylet 776a-776c can be loaded into the catheter 730 after the catheter is inserted into the patient. This allows the catheter 730 to be introduced quickly and easily in its straight configuration. This further allows the surgeon to access a region of the body and determine a stylet with an appropriate curvilinear configuration without having to make inferences or rely on previous diagnoses.

  Referring again to FIGS. 16A-16B, if desired, the control handle 732 can further include an attachment structure for selective attachment to the endoscope. In one embodiment, the catheter 730 is connected to the control handle by a connector coupling 770 that can act, for example, as strain relief. As best shown in FIG. 20, the connector device 770 can be configured in a manner that fits snugly into the biopsy port (BP) of the endoscope 124, thus serving as a mounting structure. . When attached in this manner, the catheter 730 is aligned with the longitudinal axis of the biopsy port (BP). In an alternative embodiment, a rigid extension tube can be placed in the biopsy port and its free end can receive the distal end of the connector fitting 770.

  In accordance with another aspect of the present invention, alternative methods and configurations may be utilized to affect the selective orientation change of the distal end of the catheter described herein. To that end, the following description includes some examples of control handles and / or steering mechanisms that can be utilized to change the orientation of the distal end of the catheter 130. Although exemplary embodiments of a control handle / steer mechanism are described below for use with the catheter 130, the control handle / steer mechanism aspects described below have a wide range of uses and catheters other than the catheter 130. It will be appreciated that it is suitable for use with other orientable medical devices such as endoscopes, fiberscopes, steerable guidewires, and the like. For this reason, the following description and referenced figures are exemplary in nature and should not be construed as limiting the scope of the invention as set forth in the claims.

  FIG. 21 illustrates one embodiment of a control handle 832 that may be suitable for use with a catheter 130 or other conventional catheter that is redirected by one or more offset steering wires. In this embodiment, the control handle 832 can be selectively attached to the biopsy port (BP) of the endoscope 124 while simultaneously or subsequently passing through the biopsy port (BP) of the endoscope. A catheter 130 attached to the control handle 832 can be slidably delivered. As best shown in FIG. 21, the control handle 832 includes a steering mechanism 840, at least one access port 844, and a control handle 832 of a biopsy port or endoscope, as will be described in more detail below. A mounting structure 848 configured to be selectively mounted in the peripheral region is included.

  As best shown in the cutaway view of the control handle 832, the steering mechanism 840 of the control handle 832 includes first and second control knobs 852 and 854 that are rotatably held on the central shaft 856, respectively. . Central axis 856 defines a longitudinal bore 860 having a longitudinal axis. As described in more detail below, the longitudinal bore 860 includes a first opening 862 at one end of the central shaft 856 for receiving the distal end of the catheter 130 and a control handle at the distal end of the catheter 130. A second opening 864 at the opposite end for exiting 832. The first and second control knobs 852 and 854 are mounted on the central shaft 856 so as to rotate about their longitudinal axes.

  Base section 870 extends from the bottom of central axis 856. The base section 870 includes a third opening (not shown in FIG. 21) to which the proximal end 130 of the catheter is selectively or permanently connected. At least one access port 844 is disposed in the base section 870 for accessing one or more channels of the catheter 130. Base section 870 further includes suitable passages (not shown) that are routed through base section 870 to control knobs 852 and 854. The passageway is sized and configured to freely route the proximal end of the steering wire (not shown) of the catheter 130 to the control knob, where the proximal end of the steering wire is connected to the control knob in a conventional manner. It is fixed.

  In accordance with one embodiment of the present invention, the control handle 832 further includes a mounting structure 848. In the illustrated embodiment, the attachment structure 848 is configured to selectively attach the control handle 832 to the biopsy port (BP) of the endoscope. In the illustrated embodiment, the mounting structure 848 is positioned so that the longitudinal axis of the central axis 856 is coaxial with the axis of the biopsy port (BP) when the control handle 832 is mounted on the endoscope. ing. In one embodiment, the attachment structure 848 can be comprised of a counterbore 884 and a resilient joint member 888 that are concentrically disposed with the longitudinal bore 860 of the central shaft 856. Counterbore 884 communicates with second opening 864 and is larger than this. A resilient joint member 888 such as a rubber brush is mounted in the counterbore 884. The resilient coupling member 888 further includes a through-hole 890 that is sized and configured to be mounted on the biopsy port structure in a removable and safe manner. The resilient coupling member through-hole 890 can include an introducer to facilitate insertion of the biopsy port structure.

  During assembly, the control handle 832 is detachably mounted on the biopsy port (BP) by the mounting structure 848. Catheter 130 extends from base section 870, loops into first opening 862 of control handle 832, and is inserted into first opening 862. The catheter 130 is then routed through the longitudinal bore 860 of the central shaft 856 and exits the control handle 832 through the second opening 864. As will be described in more detail below, the distal end 130 of the catheter can exit the second opening 864 and be inserted into a biopsy port (BP) of the endoscope 124. The first and second sets of steering wires pass freely through the channel of the base section 870 from the proximal end 130 of the catheter, the proximal end of which is driven by rotation of the first and second control knobs 852 and 854. Terminate with fixed connections to the first and second control knobs 852 and 854 in a conventional manner in which tension is selectively applied to the first and second sets of steering wires. In use, rotation of the first or second control knob 852 and 854 selectively tensions the steering wire, which in turn causes the distal end 130 of the catheter to reorient in one or more planes. . When the control handle 832 is mounted on the biopsy port (BP), the catheter 130 is simultaneously further advanced through the working channel of the endoscope by manually pushing the catheter into the first opening 862 of the control handle. be able to.

  FIG. 22 illustrates another embodiment of the control handle 932. The control handle 932 is substantially similar in construction, material and operation to the control handle shown in FIG. 21, except for the differences described below. In this embodiment, the steering mechanism 940 of the control handle 932 is in the form of a joystick 950 instead of two rotating knobs. The first end of the joystick 950 is pivotally mounted in a conventional manner within the handle housing 936 and preferably provides full 360 ° movement. The opposite end of the joystick 950 extends from the control handle 932 and is configured so that the user can hold it with one hand. A set of first and second steering wires (not shown) extends from the proximal end of the catheter 130 and is routed through a suitable conduit in the base section and is conventional with the first end of the joystick. Terminate with a connection of. Thus, pivotal movement of the joystick 950 in one or more directions causes the distal end of the catheter 130 to turn due to the selective tension of the steering wire. Joystick 950 is further configured with a longitudinal bore (not shown in FIG. 22) that communicates with the counterbore of the mounting structure. The longitudinal holes define first and second openings (not shown) for the catheter's inlet and outlet to the control handle 932.

  During assembly, the control handle 932 is detachably mounted on the biopsy port by an attachment structure. Catheter 130 extends from base section 970, loops to a first opening in control handle 932 formed by joystick 950, and is inserted into the first opening. The distal end of the catheter 130 is then routed through the longitudinal hole of the joystick 950 and exits the control handle 932 through the second opening. As will be described in more detail below, the catheter can exit the second opening and be inserted into a biopsy port (not shown in FIG. 22) of the endoscope 124. In a conventional manner, a first and second set of steering wires (not shown) from the proximal end of the catheter 130 freely pass through the passage in the base section 970, the proximal end of which is a pivoting joystick 950. Terminates in a fixed connection to the first end of the joystick 950 so as to selectively tension the first and second sets of steering wires.

  In use, pivoting the joystick 950 selectively tensions the steering wire, which in turn causes the distal end of the catheter 130 to turn in one or more planes. When the control handle 932 is mounted to the biopsy port by a mounting structure (not shown in FIG. 22), the catheter 130 is simultaneously pushed into the first opening of the joystick 950 to manually push the catheter 130 into the endoscope. Further progress can be made in the 124 working channels. In particular, with one hand, the surgeon can advance and steer the catheter simultaneously. This can be accomplished by holding the catheter 130 directly over the joystick 950. The catheter 130 can be advanced by an axial force that pushes the distal end 130 of the catheter into the joystick 950 and can be simultaneously operated by movement of the lateral or pivoting joystick 950. A locking mechanism (not shown) can optionally be provided to hold the joystick 950 in a selected position, if desired.

  FIG. 23 illustrates another embodiment of a control handle 1032 that can cause a change in orientation of the distal end of the catheter 1030. Control handle 1032 includes a handle housing 1036 having a proximal end 1040 and a distal end 1042. The handle housing distal end 1042 is operatively connectable to the proximal end of the catheter 1030. The control handle 1032 can include one or more access ports 1046 that communicate with one or more channels of the catheter 1030. Port 1046 is connected in communication with the catheter channel through one or more conduits (not shown) that route through handle housing 1036.

  The control handle 1032 further includes a steering mechanism 1060 for redirecting the distal end of the catheter in one or more planes. In the illustrated embodiment, the steering mechanism 1060 includes first and second knobs 1062 and 1064, a circular swash plate 1066, and a mechanical linkage 1068 that interconnects the first and second knobs 1062 and 1064 and the circular swash plate 1066. including. A circular swashplate 1066 is mounted within the handle housing 1036 on a central pivot 1070 that is generally aligned with the proximal end of the catheter. Center pivot 1070 is a spherical structure supported by pivot base 1072. As shown, the proximal end of the catheter steering wire (SW) passes through the handle housing 1036 and is equidistantly spaced radially inward from its outer peripheral end 1076 around the circumference of the circular swashplate 1066. Connected in position. For example, in a 4-wire structure, the wires are connected to the circular swash plate 1066 at 90 ° intervals. In the three-wire structure, the steering wire is connected to the circular swash plate 1066 at 120 ° intervals.

  The second knob 1064 is rotatably mounted on the handle housing 1036 at a position where the rotation axis thereof is coaxial with the center pivot 1070. The second knob 1064 defines a cylindrical through hole 1080 that is offset from its axis of rotation. The through hole 1080 of the second knob 1064 rotatably receives the first knob shaft 1082 of the first knob 1062. When assembled, the first knob shaft of the first knob 1062 extends through the through hole 1080 of the second knob 1064 and reaches the handle housing 1036. Thus, the first knob 1062 is rotatably supported by the second knob 1064. The handle housing 1036 includes a circular slot 1088 through which the first knob shaft 1082 extends, the reason for which will be described in detail below. The first knob shaft 1082 defines an internal threaded hole 1086.

  As illustrated in FIG. 23, the mechanical linkage 1068 transmits the rotational movement of the knob to the pivoting movement of the swash plate 1066 and then to the translational movement of the steering wire (SW). First and second knobs 1062 and 1064 and swash plate 1066 are attached to each other. In the embodiment illustrated in FIG. 23, the mechanical linkage 1068 has a hook 1090 at one end that spans under the outer peripheral edge 1076 of the circular swashplate 1066 and an internal threaded hole 1086 in the first knob shaft 1082 at the opposite end. Including a lead screw 1094 which is coupled by a screw. Thus, rotation of the first knob 1062 translates the mechanical linkage linearly within the internal threaded bore of the first knob shaft 1082. The hook 1090 contacts the circular swash plate 1066 due to, for example, upward translational movement of the mechanical linkage 1068, which in turn causes the circular swash plate 1066 to pivot relative to the central pivot 1070. As the swashplate 1066 pivots about the central pivot 1070, the swashplate 1066 pulls one or more steering wires (SW) and turns the distal end of the catheter 1030 in the desired direction.

  To turn the distal end 1030 of the catheter in different directions, the second knob 1064 is rotated clockwise or counterclockwise depending on the desired orientation to be changed. The rotation of the second knob 1064 causes the first knob 1062 to rotate about the axis of the second knob 1064 through the circular slot 1088 of the handle housing 1036. Therefore, the hook 1090 rotates around the circular swash plate 1066. When the hook 1090 reaches the desired position, the first knob 1062 rotates to change the angle of the pivot swashplate 1066 and thus the angle of orientation of the catheter distal end, as previously described. Can do.

  In an alternative embodiment, both the first and second knobs 1062 and 1064 can be mounted in alignment with the central pivot axis. In this embodiment shown in FIG. 24, the shaft 1082 of the first knob 1062 is rotatably received within the central hole 1080A of the second knob 1064. The shaft 1082 of the first knob 1062 extends past the second knob 1064 and terminates as a gear 1092. Gear 1092 is in meshing engagement with gear teeth 1094 located about second shaft 1096 that are pivotally supported for rotation to the bottom of second knob 1064 on the handle housing. Second shaft 1096 defines an internally threaded hole 1098 into which mechanical linkage 1068 is engaged by a screw. Therefore, when the second knob 1064 rotates, the second shaft 1096 rotates around the gear 1092 of the first knob 1062. As the first knob 1062 rotates, the gear 1092 of the first knob 1062 rotates the gear shaft 1096 so that the mechanical linkage 1068 translates linearly and the circular swashplate tilts, thus causing the distal end of the catheter to move. Change direction.

  FIG. 25 shows another embodiment of a control handle 1132 for redirecting the distal end of the associated catheter 130. Control handle 1132 defines a proximal end 1134 and a distal end 1136 to which the proximal end of the catheter is operatively connected. The handle 1132 further includes a steering mechanism 1140 in the form of one or more depressible buttons 1150 that can separately actuate one or more steering wires (SW) to change the orientation of the distal end 130 of the catheter. including. It will be appreciated that the number of pushable buttons 1150 corresponds to the number of control wires (SW). For example, a catheter having two sets of steering wires is connected to a handle having four depressible buttons, and a catheter having three steering wires is connected to a handle having three depressible buttons and the like. The control handle 1132 is preferably ergonomically configured to be grasped by the surgeon's hand, and the placement of the button 1150 is such that the button 1150 can be pressed by the surgeon's finger.

  To help identify the button 1150, the top of each depressible button 1150 can include a recess, groove, or convex structure. In the illustrated embodiment, the depressible button 1150 is depressed and actuated along an axis perpendicular to the longitudinal axis of the catheter 130. However, the catheter can be positioned so that the longitudinal axis of the catheter 130 is substantially parallel to the axis of movement of the depressible button 1150. It will be appreciated that a mechanical linkage such as a rocker arm, lever, crank, or combination thereof may be used to convey the movement of the button 1150 to the tension on the steering wire. Access to the channel of catheter 130 may be provided by an access port (not shown) located on the handle or via a breakout box or other structure connected to the catheter that is separate from the handle. it can.

  FIG. 26 illustrates another embodiment of a control handle 1232 for changing the orientation of the distal end of the associated catheter 130. In this embodiment, the control handle 1232 is configured to be mounted on the forearm and hand of a user such as a surgeon. The control handle 1232 includes a curved surface 1238 that is sized appropriately for mounting on the surgeon's forearm and hand. The control handle 1232 defines an opening (not shown in FIG. 26 for the catheter) to which the proximal end 130 of the catheter is connected at one end. The control handle 1232 further includes one or more access ports (not shown) that communicate with the channels of the catheter 130 through one or more passages. The control handle 1232 further includes a steering mechanism 1240 for redirecting the distal end 130 of the catheter. In the illustrated embodiment, the steering mechanism 1240 includes a cap-like structure 1250 that can be attached to one finger of a surgeon. The cap-like structure 1250 is connected to one or more steering wires (SW) of the catheter 130. For this reason, the distal end 130 of the catheter is steered in a direction in which the steering wire (SW) is tensioned by the movement of the surgeon's finger. It is envisioned that the surgeon's hand movement in performing functions such as endoscopic manipulation, such as using biopsy forceps, does not interfere with the surgeon's ability to maneuver / hold the position of the catheter.

  In accordance with another aspect of the invention, to amplify the input movement of a steering input device (eg, steering knob, slide, dial, joystick, etc.) whose movement is used to control the orientation of the distal end of the catheter, It may be desirable to configure a control handle control function such as a steering mechanism. Amplifying the input distance of the input device results in a greater change in the orientation of the catheter distal end as greater axial movement of the steering wire is achieved. A greater change in orientation of the distal end of the catheter from a smaller movement of the input device can provide many advantages. For example, this allows for the configuration of a smaller steering mechanism, which allows for a smaller handle of a medical device (eg, a catheter, endoscope, or other control handle). To that end, some exemplary embodiments of a steering mechanism suitable for use with a control handle, such as the handle of a medical device, can be used to amplify the movement of the steering input device and thus change the orientation of the distal end of the larger catheter. The achievement will be described in detail below.

  FIG. 27 shows one embodiment of a control handle 1332 adapted to functionally attach to a catheter, such as catheter 130, having one or more steering wires (SW) secured to its distal end. The control handle 1332 includes a handle housing 1336 in which an exemplary steering mechanism 1340 is operably mounted. The steering mechanism 1340 of the control handle 1332 is configured to redirect the distal end 130 of the catheter by selective axial translation of the steering wire (SW) of the catheter 130. The steering mechanism 1340 includes a steering input device 1344 and one or more motion amplification devices 1348. A steering input device 1344 is coupled to a portion of each steering wire (SW) by a motion amplification device 1348. Accordingly, the axial translation of one or more steering wires (SW) is affected by the movement of the steering input device 1344 by the one or more motion amplification devices 1348. As will be described in more detail below, the motion amplification device 1348 amplifies the movement of the steering input device 1344 (ie, the translational distance, sometimes referred to herein as a stroke), so that the larger axis of the steering wire (SW) Directional movement occurs, which results in a greater angle of change in the orientation of the distal end of the catheter.

  In the embodiment shown in FIG. 27, the steering input device 1344 is a joystick having an elongated portion 1352 at its first end and a semicircular swashplate 1354 at its second end. A joystick semi-circular swash plate 1354 is pivotally mounted to the handle housing on a central pivot 1358, such as a spherical structure. The semicircular swash plate 1354 can swivel up to 360 degrees on the central swivel axis. Around the outer end of the swash plate 1354, there are provided a plurality of connection flanges 1360 on which a plurality of motion amplification devices 1348 are mounted in a supportive manner. In this embodiment, motion amplification device 1348 is a pulley (hereinafter referred to as pulley 1348), and one pulley 1348 is supportably mounted on each connecting flange. Each pulley 1348 is mounted for rotation on each connection flange 1360 and defines a rotation axis that is generally perpendicular to the longitudinal axis of the catheter 130 at the connection of the catheter to the distal end of the control handle 1332.

  When assembled, the proximal end of the steering wire (SW) extends from the proximal end of the catheter 130 on the pulley 1348, beyond the pulley 1348, and anchored to a fixed position 1366 within the handle housing 1336. Returned to and sent. In use, the joystick elongate portion 1352 can be grasped by the user and can be pivoted about the central pivot 1358 so that one or more of each pulley 1348 can be moved by moving one or more connecting flanges 1360. Will move. Movement of the pulley 1348 creates tension in one or more steering wires (SW), causing the steering wire (SW) to translate axially to change the orientation of the distal end of the catheter 130.

  By utilizing an engineering mechanism to move a pulley 1348 in the manner described below, interconnecting a steering wire (SW) to an input device 1344 (eg, joystick), the multiplication factor (in this case, the multiplication factor is 2). A greater axis of the steering wire (SW) than by attaching the proximal end of the steering wire directly to the connecting flange without a pulley by amplifying the movement of the input device 1344 (measured at the connecting flange) by It will be appreciated that direction movement occurs. It will be appreciated that additional pulleys can be used and configured using techniques known to those skilled in the art to further enhance the multiplication effect.

  FIG. 28 shows a partial view of another embodiment of a control handle 1432 using a steering mechanism 1440 that amplifies the input movement of the input device to redirect the distal end of the catheter. The control handle 1432 is substantially similar in structure, material, and operation to the control handle shown in FIG. 27, except for the differences described below. Control handle 1432 includes a handle housing 1436 in which an exemplary steering mechanism 1440 is operably mounted. The control handle steering mechanism 1440 includes a steering input device 1444 and one or more motion amplification devices 1448. In the illustrated embodiment, the input device 1444 is a joystick 1450 and the motion amplification device 1448 is one or more spools (hereinafter referred to as a spool 1448). For convenience of illustration, only one spool is shown, but it will be understood that one spool corresponds to one steering wire of the catheter. Thus, in an embodiment using a four steering wire catheter, the control handle includes four spools spaced 90 degrees apart. The joystick 1450 includes a shaft portion that can be grasped at one end and a swash plate 1454 at the other end. The joystick 1450 is mounted on a central pivot 1458 that is pivotally fixed to a handle housing 1436 on a swash plate 1454. The swash plate 1454 includes a flange member 1460 (not shown), which is connected to each spool 1448 by a wire 1468 as described in more detail below.

  The spool 1448 is rotatably mounted on the handle housing 1436. Each spool includes first and second spool sections 1462 and 1464 having diameters D1 and D2, respectively. In this embodiment, the diameter D2 is larger than the diameter D1. A wire 1468 connecting the swash plate 1454 to the spool 1448 is wound around a first spool section 1462 having a smaller diameter. The proximal end of the steering wire (SW) of the catheter (not shown) is partially wound around the larger diameter second spool section 1464 and is fixedly connected thereto.

  According to an engineering mechanism, the spool 1448 acts like a wheel and shaft mechanism that amplifies the movement of the input device with a multiplication factor determined by the diameters of D1 and D2. In particular, it provides a force applied by the input device 1444 to the outer periphery of the smaller diameter first spool section 1462 (ie, shaft) and to the outer periphery of the larger diameter second spool section 1464 (ie, wheel). By providing resistance from the steering wire SW, the distance of the input device 1444 is amplified at a ratio of D2: D1 (ie, the multiplication factor is the ratio of D2: D1). Thus, smaller movement of the joystick 1450 results in a greater orientation change of the distal end of the catheter. It will be appreciated that the ratio of diameter D2: diameter D1 may vary depending on the movement of the steering wire movement.

  FIGS. 29-31 show another embodiment of a control handle 1532 that uses a steering mechanism 1540 that amplifies the input movement of the input device to redirect the distal end of the catheter. Control handle 1532 is substantially similar in configuration, material, and operation to the control handle illustrated in FIGS. 27 and 28, except for the differences described below. Control handle 1532 includes a handle housing 1536 in which an exemplary steering mechanism 1540 is operably mounted. The control handle steering mechanism 1540 includes a steering input device 1544 and one or more motion amplification devices 1448.

  In this embodiment, the input device 1544 is a joystick 1550 and the motion amplification device 1448 is one or more bell cranks (hereinafter referred to as bell cranks 1548). For convenience of illustration, only one bell crank is shown, but it will be understood that one bell crank corresponds to one steering wire (SW) of the catheter 130. Thus, in embodiments utilizing a four steering wire catheter, the control handle 1532 includes four bell cranks 1548 spaced 90 degrees apart. The joystick 1550 includes a shaft portion 1552 that can be grasped at one end and a spherical member 1554 at the other end. The joystick 1550 is pivotally mounted on a fixed support 1558 defined by or coupled to a handle housing 1536 at a spherical member 1554. Joystick 1550 includes one or more flange members 1560 that are integrally formed with the spherical member and extend laterally therein. The number of flange members 1560 corresponds to the number of steering wires (SW), that is, the number of bell cranks 1548.

  Each bell crank 1548 is pivotably mounted within the handle housing 1536 about a pivot axis 1566 disposed perpendicular to the longitudinal axis of the steering wire. Each steering wire (SW) of the catheter 130 is connected to a corresponding bell crank 1548 at a first connection 1570 spaced from the pivot axis 1566 by a radial distance Rl. The bell crank 1548 is coupled to a corresponding flange member 1560 of the joystick 1550 via a linkage 1574 at a second connection 1572 spaced a distance R2 from the pivot axis 1566. The linkage 1574 can be a flexible linkage such as a wire, or a rigid linkage such as a link or bar. Thus, the steering wire (SW) is connected to the joystick 1550 by the bell crank 1548.

  In use, the joystick 1550 can be grasped by the surgeon and swiveled in one or more directions so that one or more steering wires (SW) can be moved axially to distant the catheter 130. It causes a change in the orientation of the top edge. As the joystick 1550 pivots, the flange member 1560 formed integrally therewith also pivots to define the input distance or stroke. A force is applied to the linkage 1574 by movement of the flange member 1560 due to the input stroke, causing the linkage 1574 to translate by a selected distance. Translation of the linkage 1574 then causes the bell crank 1548 to rotate counterclockwise about its pivot 1566 as illustrated in FIG. As the bell crank 1548 rotates, each steering wire (SW) is pulled to connect the steering wire (SW) to the bell crank 1548, causing the steering wire (SW) to translate from the distal end of the catheter 130. Translation of the steering wire (SW) causes the distal end of the catheter 130 to turn in the selected direction. Thus, a resistance force is applied to the bell crank 1548 by the steering wire (SW).

  According to an engineering mechanism, by attaching the steering wire (SW) to the input device 1544, i.e., joystick 1550, by means of the bell crank 1548 as shown and described, the bell crank 1548 is larger than the steering wire (SW). Amplify the input distance or stroke of the joystick 1550 by the multiplication factor determined by Rl and R2 to achieve axial movement. In particular, applying a force applied by the input device 1544 on the bell crank 1548 at a distance R2 from the pivot axis 1566 and applying a resistance force from the steering wire (SW) on the bell crank 1548 at a distance Rl from the pivot axis 1566. Thus, the input distance or stroke of the input device 1544 is amplified by a ratio of R1: R2 (ie, the multiplication factor is a ratio of R1: R2). Since the distance Rl between the first connection 1570 and the pivot axis 1566 of the bell crank 1548 is greater than the distance R2 between the second connection 1572 and the pivot axis 1566 of the bell crank 1548, the bell crank 1548 is The input device stroke is amplified by a ratio, ie, a multiplication factor greater than one. It will be appreciated that the ratio of R1: R2 can be varied to provide greater or lesser steering wire movement.

  The control handle described above with respect to FIGS. 27-31 can include other features described below. The control handle can include one or more access ports, such as port 1556 shown in FIGS. An access port, such as access port 1556, is connected in communication with one or more channels provided on the catheter, thus providing access via the catheter channel from outside the control handle to the distal end of the catheter. . For example, the access port 1556 can be attached to an appropriately configured catheter working channel, wash channel, and / or viewing device channel.

  The control handle may optionally include an attachment structure for selectively attaching the control handle to an associated endoscope or other structure such as a surgical cart. The attachment structure can be formed integrally with the handle or can be a separate device or assembly that attaches the control handle to the associated structure. The attachment structure can be a structure that can selectively attach the control handle to a desired object. Such attachment structures can include straps, clamshell type clamps, connectors, brackets and can depend on the object to which the control handle is attached. For example, a clamp may be more suitable for attachment to a surgical chart, and a strap, bracket, etc. may be more suitable for attachment to other medical device endoscopes.

  In the embodiment illustrated in FIGS. 30 and 31, control handle 1532 can be selectively attached to endoscope 124 via attachment structure 1588. As best shown in FIG. 31, the mounting structure 1588 includes an armature 1590 that is integrally molded to a clamshell type bracket 1592. As shown in FIG. 31, the bracket 1592 is configured to be selectively attached around a part of the endoscope body. The bracket 1592 includes left and right bracket halves 1592a and 1592b that enclose the body of the endoscope 124. Bracket halves 1592a and 1592b are pressed together at each end by fasteners 1594, such as bolts, to securely attach attachment structure 1588 to endoscope 124. The armature 1590 is illustrated for the distal portion (shown for the control handle 1532 of FIG. 31) that defines a control handle connection interface (not shown for the control handle 1532) for selective attachment to the control handle 1532. Not included).

  In one embodiment, the control handle interface provides an attachment protrusion 1596 of the control handle 1532 to allow the control handle 1532 to be adjustably rotated relative to the attachment structure 1588 between preselected fixed positions. (See FIG. 30) are cooperatively configured to receive. For example, in one embodiment, the mounting protrusion 1596 can be formed with a detent 1598 that properly cooperates with the control handle mounting interface to form a regularly spaced motion mechanism. Thus, the rotational movement of the control handle 1532 can be moved at regular intervals between fixed positions with respect to the mounting structure 1588. Thus, the control handle 1532 can have many orientations relative to the endoscope 124 when selectively mounted therein. For example, the longitudinal axis of the control handle 1532 may be perpendicular to the central axis of the endoscope biopsy port (BP) or a desirable acute or obtuse angle with respect to the central axis of the endoscope biopsy port (BP). it can.

  The above aspect of the present invention allows the catheter assembly to be mounted on the handle of the endoscope so that the surgeon can operate both the endoscope and the catheter assembly using both hands. As a result of connecting the catheter assembly to the endoscope, the catheter 130 is known as a service loop before entering the biopsy port (BP), as shown in FIGS. Create a loop. In some examples, this can cause binding or friction of instruments, wires, etc. in slidable movement within the catheter in use. To this end, several exemplary configurations can be used to relax these possible constraints, as will be described in detail below.

  Referring now to FIG. 32, there is shown one exemplary embodiment of a catheter assembly 1628 comprised of a catheter 1630 and a control handle 1632 mounted on an associated endoscope 124 for use herein. . In the illustrated embodiment, the catheter 1630 helps reduce catheter constraint and uses a specific configuration that helps guide the distal end of the catheter 1630 to the biopsy port (BP) of the associated endoscope 124. ing. The control handle 1632 includes an input steering device 1644 for control of changes in catheter orientation. Catheter 1630 defines a proximal end 1650 and a distal end. The proximal end 1650 of the catheter 1630 is functionally attached to the control handle 1632. The catheter 1630 further includes one or more steering wires (SW) that are anchored to the distal end 1630 of the catheter and extend past the proximal end 1650 of the catheter 1630 for connection to the steering input device 1644. The steering wire (SW) is movable within the catheter 1630 as a result of actuation of the steering input device 1644 that causes the distal end of the catheter 1630 to change orientation.

  In one embodiment, a catheter 1630 is formed with a distal section (not shown for an endoscope in FIG. 32) and a proximal section 1656 that can be turned. In the illustrated embodiment, the proximal section 1656 includes first and second semi-rigid or rigid segments 1664 connected by a flexible segment 1660 and a hinge, as schematically shown in FIG. 1668. In this embodiment, the first and second semi-rigid or rigid segments 1664 and 1668 and flexible segment 1660 of the proximal section are interconnected by first and second hinge mechanisms 1672 and 1676. . Each of the hinge mechanisms 1672 and 1676 includes an upper section and a lower section 1680 and 1682 that are connected to each other by a hinge via a central cylindrical shaft 1686 as best shown in the cross-sectional view of FIG. .

  The first semi-rigid or rigid section 1664 is connected to either the upper or lower section of the first hinge mechanism 1672 and the second semi-rigid or rigid section 1668 is connected to the upper or lower section of the first hinge mechanism 1672. Connected to the other end of the section. Similarly, the second semi-rigid or rigid section 1668 is connected to either the upper section or the lower section of the second hinge mechanism 1676 and the flexible segment 1660 is connected to the upper section of the second hinge mechanism 1676. Or it is connected to the other of the lower sections. When assembled, the upper and lower sections of hinge assemblies 1672 and 1676 define an internal cavity 1690. Hinge assemblies 1672 and 1676 further include a set of pulleys 1694 that are rotatably mounted on a central axis within internal cavity 1690. The pulley 1694 is configured to change the direction of the steering wire SW as the steering wire SW moves laterally through the catheter 1630.

  In use, the control handle 1632 is mounted on the endoscope 124 such that the catheter 1630 extends at an angle from the axis of the biopsy port (BP). In the illustrated embodiment, the control handle 1632 is rotatably mounted on the endoscope 124. However, in another embodiment, the control handle 1632 can be securely attached to the endoscope 124 in a fixed position. When the distal end of the catheter 1630 is advanced to the biopsy port (BP) of the associated endoscope 124, the segments 1660, 1664, and 1668 rotate relative to each other, and the distal section and flexible The longitudinal axis of the segment 1660 allows it to remain substantially coaxial with the central axis of the biopsy port BP so that the catheter is guided to the biopsy port (BP).

  Referring now to FIG. 34, another embodiment of a catheter assembly 1728 mounted on an associated endoscope 124 for use therein is shown. In the illustrated embodiment, the catheter assembly 1728 uses a particular configuration that helps reduce catheter restraint and helps guide the distal end of the catheter to the associated endoscopic biopsy port. As best shown in FIG. 34, the catheter assembly 1728 is movably attached to the endoscope 124 by a slide bar mechanism 1740. The slide bar mechanism 1740 is attached to the endoscope 124 permanently or removably. Slide bar mechanism 1740 includes a bracket 1748 at one end for attaching slide bar mechanism 1740 to endoscope 124. Slide bar mechanism 1740 further includes an elongated member 1750 attached to bracket 1748. When attached here, the slide bar member 1750 extends outward from the endoscope 124 and extends parallel to the central axis of the biopsy port BP.

  In this embodiment, the control handle 1732 includes a lateral extension 1760 having a through hole 1762 that receives the slide bar member 1750. The through-hole 1762 is positioned so that the catheter 130 is substantially aligned with the biopsy port (BP) when fed over the slide bar member 1750. In use, the lateral extension 1760 of the control handle 1732 causes the slide bar member 1750 to guide insertion of the catheter 130 into the biopsy port (BP) as the catheter 130 advances through the biopsy port (BP). It is sent on the slide bar member 1750. Thus, by aligning the catheter 130 with the central axis of the biopsy port (BP), the slide bar mechanism 1740 assists in the insertion of the catheter 130 and reduces the restriction of the proximal section of the catheter.

  In principle, exemplary embodiments and embodiments of the invention have been described above. However, embodiments of the invention intended to protect are not limited to the specific embodiments disclosed. Furthermore, the embodiments described herein are to be considered illustrative rather than limiting. Variations and modifications may be made by others and equivalents used without departing from the spirit of the invention. Accordingly, it is expressly intended that all such variations, modifications, and equivalents are within the spirit and scope of the present invention.

  Embodiments of the invention that claim exclusive rights or privileges are defined below.

FIG. 1 is a front view of an exemplary embodiment of an in-vivo visualization system constructed in accordance with an aspect of the present invention. FIG. 2 is a cross-sectional view of the insertion tube of the endoscope shown in FIG. FIG. 3 is a perspective view of one embodiment of a catheter assembly constructed in accordance with aspects of the present invention. FIG. 4 is a perspective view of the catheter assembly shown in FIG. 3 with half of the housing removed. 5A-5C show cross-sectional views of suitable embodiments of catheters constructed in accordance with aspects of the present invention. FIG. 6A is a partial view of one suitable embodiment of a catheter body constructed in accordance with aspects of the present invention. FIG. 6B is a partial view of a suitable embodiment of a catheter formed by taking the catheter body of FIG. 6A and wrapping the catheter body with a reinforcing sheath. FIG. 6C is a partial view of a suitable embodiment of a catheter formed by taking the catheter of FIG. 6B and wrapping the catheter with an outer sleeve. FIG. 7 is a cross-sectional view of the catheter at plane 7-7 shown in FIG. 6C. 8A-8C are cross-sectional views of suitable embodiments of catheters constructed in accordance with aspects of the present invention. 9A-9C are cross-sectional views of suitable embodiments of catheters constructed in accordance with aspects of the present invention. FIG. 10 is a partial perspective view of the catheter handle with the control knob removed to illustrate the locking lever. FIG. 11 is a partial cross-sectional view of a catheter handle illustrating a suitable embodiment of an irrigation port connected to the catheter irrigation lumen. FIG. 12 is a partial cross-sectional view of the catheter handle showing the steering mechanism and optional locking mechanism. 13A is a front exploded perspective view of components of the locking mechanism of FIG. 13B is a rear exploded perspective view of components of the locking mechanism of FIG. FIG. 14 is a partial perspective view of the catheter handle of FIG. 11 illustrating one suitable embodiment of an endoscope attachment device. FIG. 15 is a cross-sectional view of one embodiment of a Y connector formed according to aspects of the present invention when assembled with a catheter. FIG. 16A is a front perspective view of another embodiment of a catheter assembly formed in accordance with aspects of the present invention. 16B is a rear perspective view of the catheter assembly of FIG. 16A. FIG. 16C is an end view of one embodiment of a catheter suitable for use with the catheter assembly of FIG. 16A. FIG. 17A is one embodiment of a stylet suitable for use with the catheter assembly of FIGS. 16A-16C, where the stylet includes a pre-formed distal end region. FIG. 17B shows the stylet of FIG. 17A inserted into the proximal section of the catheter according to aspects of the present invention. FIG. 17C shows the stylet of FIG. 17A inserted into the distal section of the catheter shown in FIG. 17B. FIG. 18A is another embodiment of a stylet suitable for use with the catheter assembly of FIGS. 16A-16C. The stylet is illustrated in its straight configuration. FIG. 18B shows the stylet of FIG. 18A in its bent distal end region configuration. FIG. 18C shows the stylet of FIG. 18A inserted into the proximal section of the catheter according to aspects of the present invention. 18D shows the stylet of FIG. 18A inserted into the distal section of the catheter shown in FIG. 18C. FIG. 19A is another embodiment of a stylet suitable for use with the catheter assembly of FIGS. 16A-16C, where the stylet includes a pre-formed distal end region. FIG. 19B shows the stylet of FIG. 19A inserted into the distal section of a catheter according to aspects of the present invention. FIG. 20 is a plan view of the catheter assembly shown in FIGS. 16A-16, selectively coupled to one suitable embodiment of an endoscope. FIG. 21 is a front view of another exemplary embodiment of a catheter assembly selectively coupled to one suitable embodiment of an endoscope. FIG. 22 is a perspective view of another exemplary embodiment of a catheter assembly selectively coupled to one suitable embodiment of an endoscope. FIG. 23 is a longitudinal cross-sectional view of one embodiment of a control handle that can change the orientation of the distal end of an associated catheter. 24 is a partial view of an alternative embodiment of a steering mechanism suitable for use with the control handle of FIG. FIG. 25 is a plan view of another embodiment of a control handle that can change the orientation of the distal end of the associated catheter. FIG. 26 is a perspective view of yet another embodiment of a control handle that can change the orientation of the distal end of the associated catheter. FIG. 27 is a longitudinal cross-sectional view of one embodiment of a control handle formed in accordance with aspects of the present invention that utilizes a steering mechanism that amplifies input movement of the input device to changes in the orientation of the distal tip. FIG. 28 is a partial projection of another embodiment of a control handle formed in accordance with aspects of the present invention that utilizes a steering mechanism that amplifies input device input movement to a change in distal tip orientation. FIG. 29 illustrates another embodiment of a control handle formed in accordance with aspects of the present invention that utilizes a steering mechanism that amplifies input movement of the input device to changes in the orientation of the distal tip. FIG. 30 illustrates another embodiment of a control handle formed in accordance with aspects of the present invention that utilizes a steering mechanism that amplifies input movement of the input device to changes in the orientation of the distal tip. FIG. 31 illustrates another embodiment of a control handle formed in accordance with aspects of the present invention that utilizes a steering mechanism that amplifies input movement of the input device to changes in the orientation of the distal tip. FIG. 32 illustrates an exemplary embodiment of a catheter assembly mounted on an associated endoscope. The catheter assembly is configured to reduce possible constraints on the catheter when introduced into an endoscope. 33 is a cross-sectional view of the hinge assembly illustrated in FIG. FIG. 34 illustrates another exemplary embodiment of a catheter assembly mounted on an associated endoscope. The catheter assembly is configured to reduce possible constraints on the catheter when introduced into an endoscope. FIG. 35 illustrates one suitable embodiment of an observation device formed in accordance with aspects of the present invention.

Claims (29)

A control handle;
An insertion tube operatively connected to the control handle, the insertion tube including a channel extending longitudinally through the insertion tube;
A user actuatable control function for controlling at least one function of the medical device, the control function comprising a proximal end associated with the control handle and a free distal end associated with the insertion tube The stylet is movably carried by the control handle along at least a portion of the channel, and the stylet is inserted upon user input at the control handle. A medical device comprising: a control function capable of changing the orientation of the distal end of the tube.   The medical device according to claim 1, wherein the stylet has a first attribute in a first condition and a second attribute in a second condition.   The medical device according to claim 2, wherein the first attribute is a substantially linear shape, and the first condition is a first temperature.   The medical device according to claim 3, wherein the second attribute is a shape having a bent distal end region, and the second condition is a second temperature higher than the first temperature.   The medical device according to claim 2, wherein the first attribute is a shape, the shape is substantially linear, and the first condition includes a straight extending external force applied to the stylet.   The medical device of claim 1, wherein the user input includes advancing the stylet or actuating a control switch.   The medical device according to claim 1, wherein the stylet is selected from the group consisting of a temperature operated stylet, a superelastic stylet, a stylet having an elastic limit of less than about 2%.   The medical device according to claim 1, wherein the insertion tube includes two or more channels extending longitudinally therein.   9. The medical device of claim 8, further comprising an observation device positioned in one of the channels of the insertion tube. A medical system,
A catheter having a proximal end and a distal end, the catheter including at least one steering wire;
A control handle,
A first opening in communication with the second opening;
A mounting structure configured to selectively associate a control handle with a port of an associated endoscopic device;
A control handle including a steering input device connected to the at least one steering wire to change the orientation of the distal end of the catheter, the proximal end of the catheter to the control handle Operatively connected, the distal end of the catheter, when associated with an endoscopic device, for insertion into the port of the associated endoscopic device A medical system inserted into the first opening and exiting the second opening of the control handle.   The system of claim 10, wherein the steering input device is a joystick or at least one knob.   The system of claim 10, wherein the mounting structure is associated with the second opening.   The system of claim 10, further comprising an endoscopic device having a port, wherein the mounting structure is selectively associated with the port of the endoscopic device.   The system of claim 13, wherein the catheter can be advanced through the port of the endoscopic device while the control handle is associated with the endoscopic device.   The system of claim 13, wherein the port communicates with at least one channel of an endoscope insertion tube. A catheter having a proximal end and a distal end;
A steering wire attached to the distal end of the catheter and movable axially relative to the catheter such that the distal end of the catheter turns in at least one direction;
A handle housing operatively connected to the proximal end of the catheter at a connection interface, wherein the proximal end of the at least one steering wire enters the handle housing;
A first knob rotatably supported by the handle housing, the rotation axis of the knob being substantially parallel to the central axis of the catheter at its connection interface to the handle housing When,
A transmission for connecting the at least one knob to the steering wire.   The catheter assembly of claim 16, wherein the transmission includes a linkage mechanism.   The linkage mechanism includes a plate member mounted in the handle housing so as to be pivotable about a pivot axis, and a mechanical linkage, the pivot axis being substantially perpendicular to the rotation axis of the knob, The catheter assembly of claim 17, wherein a steering wire is connected to the plate member.   17. The second knob of claim 16, further comprising a second knob rotatably supported by the handle housing, wherein the axis of rotation of the first knob is offset from the axis of rotation of the second knob. Catheter assembly.   17. The method according to claim 16, further comprising a second knob rotatably supported by the handle housing, wherein the rotational axis of the first knob is coaxial with the rotational axis of the second knob. Catheter assembly.   21. The catheter assembly of claim 20, wherein the second knob is rotatably supported by the first knob. A device,
A control handle;
An insertion tube having a proximal section and a distal section, wherein the proximal section is operatively attached to the handle, the distal section being opposite the proximal section and the proximal section An insertion tube that can change orientation relative to the section;
A steering wire attached to the distal section of the insertion tube and movable axially relative to the insertion tube such that the distal section of the insertion tube turns in at least one direction;
An input device movably carried by the handle and adapted to control a change in orientation of the distal section, wherein the input device is relative to the handle during operation of the apparatus. An input device that is movable by
A transmission connected to the steering wire in a first portion and connected to the input device in a second portion, the transmission for changing the orientation of the distal end of the insertion tube The input device is configured to transmit movement of the input device to the steering wire and to cause axial movement of the steering wire, the transmission further comprising: A transmission configured to provide a distance amplification effect in the transmission of the movement to the axial movement of the steering wire.   The transmission includes a movable pulley attached to a portion of the input device and movable with the input device, the steering wire surrounding a portion of the movable pulley, and a fixed position of the control handle 23. The apparatus of claim 22, wherein the apparatus is fixed in.   The transmission includes a first linkage and a bell crank that is pivotally mounted on the control handle about a bell crank pivot axis, and the steering wire is a distance Rl from the pivot axis. 23. The apparatus of claim 22, wherein the apparatus is connected to the bell crank at a position, and the first linkage connects the input device to the bell crank at a second position that is a distance R2 from the pivot axis.   25. The apparatus of claim 24, wherein the distance amplification effect is determined by a ratio of R1 to R2.   26. The apparatus of claim 25, wherein Rl is greater than the distance R2.   The transmission includes the first linkage and a spool rotatably supported by the control handle, the spool having a first spool section and a second spool section, The spool section has a first diameter, the second spool section has a larger second spool section, and the steering wire is connected to the second spool section at its outer periphery; 23. The apparatus of claim 22, wherein a first linkage is connected to the first spool section at its outer periphery and is connected to the input device.   23. The apparatus of claim 22, wherein the transmission includes a motion amplification device having an amplification factor, and the movement of the steering wire is approximately equal to the movement of the input device amplified by the amplification factor of the motion amplification device. .   30. The apparatus of claim 28, wherein the motion amplification device is selected from a device group consisting of a bell crank, a pulley, and a wheelset.

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